Drugs / Carfilzomib
Carfilzomib
also known as
Kyprolis (carfilzomib) for Injection · Kyprolis · Carfilzomib (KYPROLIS) · CFZ · CAR · Carfilzomib Injection · Kyprolis (carfilzomib) · NSC-758252 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 19 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 1 milestone | |||||
| Filed | EU (EMA) | Kyprolis | plasma cell myeloma | 2015-12-05 | “submission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indication for Kyprolis” amgen.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 7 milestones | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2026-07-13 | “a New Drug Application for mezigdomide, an investigational CELMoD, in combination with carfilzomib and dexamethasone is also currently under review with the FDA” bms.com ↗ “FDA has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd).” bms.com ↗ |
| Filed | US (FDA) | KYPROLIS | relapsed/refractory diffuse large B-cell lymphoma | 2018-08-27 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) to expand the Prescribing Information for KYPROLIS ® (carfilzomib)” amgen.com ↗ |
| Filed | US (FDA) | Kyprolis | relapsed/refractory diffuse large B-cell lymphoma | 2015-09-18 | “FDA has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis ® (carfilzomib) for Injection for patients with relapsed multiple myeloma.” amgen.com ↗ |
| Filed | US (FDA) | Kyprolis | relapsed/refractory diffuse large B-cell lymphoma | 2015-07-23 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) for Kyprolis” amgen.com ↗ |
| Filed | EU (EMA) | Kyprolis | relapsed/refractory diffuse large B-cell lymphoma | 2015-01-27 | “a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma” amgen.com ↗ “In December, a Variation to the MAA was submitted to the EMA to expand the indication for Kyprolis in relapsed multiple myeloma” amgen.com ↗ “A Marketing Authorization Application (MAA) is currently under accelerated assessment in the EU for relapsed multiple myeloma.” amgen.com ↗ “the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of Kyprolis” amgen.com ↗ “a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)” amgen.com ↗ “Kyprolis is under regulatory review by the European Medicines Agency (EMA).” amgen.com ↗ |
| Filed | US (FDA) | Kyprolis | relapsed/refractory diffuse large B-cell lymphoma | 2015-01-27 | “submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA )” amgen.com ↗ “In January, an sNDA was submitted to the FDA to expand the Prescribing Information to include KYPROLIS” amgen.com ↗ “FDA has accepted the supplemental New Drug Application (sNDA) of Kyprolis” amgen.com ↗ |
| Filed | China (NMPA) | KYPROLIS | relapsed/refractory diffuse large B-cell lymphoma | — | “accepted by the China National Medical Products Administration (NMPA) for the use of KYPROLIS plus dexamethasone for the treatment of relapsed and refractory multiple myeloma.” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (9) | US (FDA) | KYPROLIS | — | 2015-07-24 – 2025-05-22 | fda.gov ↗ |
| Approved | EU (EMA) | Kyprolis | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | KYPROLIS | — | 2012-07-20 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 148 trials · 1 missed | ||||||
| Phase 1 | NCT07715903 | Oct 2026 → Dec 2029 expected | adrenal cortex carcinoma, colorectal neoplasm, intrahepatic cholangiocarcinoma, metastatic neoplasm | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06918990 | May 2026 → Jun 2027 expected | transplant rejection | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1 | NCT06249282 | Apr 2024 → Nov 2026 expected | non-small cell lung carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05651932 | Feb 2023 → Dec 2027 expected | plasma cell myeloma | K36 Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05556616 | Jan 2023 → Jun 2024 | plasma cell myeloma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05675449 | Dec 2022 → Jul 2025 overdue | plasma cell myeloma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04895410 | Jan → Jun 2022 | plasma cell myeloma | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05050097 | Sep 2021 → Mar 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03909412 | Oct 2019 → Aug 2027 expected | plasma cell myeloma | Hackensack Meridian Health | Recruiting | No outcome recorded |
| Phase 1 | NCT03798678 | Jul 2019 → Nov 2023 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03605719 | Oct 2018 → Oct 2022 | plasma cell myeloma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT03530683 | May 2018 → Jul 2024 | acute myeloid leukemia, diffuse large B-cell lymphoma, plasma cell myeloma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03432741 | Mar 2018 → Aug 2022 | Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02512926 | Feb 2016 → Aug 2021 | leukemia, refractory malignant neoplasm | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT02293109 | Dec 2015 → Dec 2017 | adult acute lymphoblastic leukemia | Mehrdad Abedi, MD | Completed | No outcome recorded |
| Phase 1 | NCT02187133 | May 2015 → Mar 2021 | non-Hodgkin lymphoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT02335983 | Apr 2015 → Oct 2019 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02269085 | Apr 2015 → May 2018 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02303821 | Feb 2015 → Jun 2024 | acute lymphoblastic leukemia | Amgen | Completed | Missed primary |
| Phase 1 | NCT02332850 | Jan 2015 → Dec 2025 | plasma cell myeloma | Thomas Martin, MD | Completed | No outcome recorded |
| Phase 1 | NCT02101944 | Dec 2014 → May 2021 | anemia, plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02442648 | Dec 2014 → Jun 2021 | — | E. Steve Woodle | Unknown | No outcome recorded |
| Phase 1 | NCT02235740 | Nov 2014 → Oct 2015 | cancer | Novartis | Terminated | No outcome recorded |
| Phase 1 | NCT01991301 | Nov 2014 → Nov 2017 | graft versus host disease | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT02142530 | Oct 2014 → Mar 2017 | diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, not otherwise specified | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02257476 | Aug 2014 → Nov 2016 | cancer | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01926665 | Jun 2014 → Sep 2017 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02199665 | Jun 2014 → Oct 2025 | plasma cell myeloma | University of Chicago | Completed | No outcome recorded |
| Phase 1 | NCT02095834 | Apr 2014 → Jan 2021 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01959698 | Apr 2014 → Jun 2020 overdue | diffuse large B-cell lymphoma | Roswell Park Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01949532 | Jan 2014 → Apr 2015 | end stage renal failure, plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01949545 | Oct 2013 → Aug 2015 | cancer, hematopoietic and lymphoid cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01980589 | Aug 2013 → Mar 2016 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01729104 | Apr 2013 → Oct 2018 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT01738594 | Mar 2013 → Oct 2016 | mycosis fungoides and variants, primary cutaneous T-cell non-Hodgkin lymphoma | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01789242 | Feb 2013 → Dec 2016 | AL amyloidosis | Criterium, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01660750 | Jan 2013 → Aug 2015 | plasma cell myeloma | Criterium, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01372540 | Feb 2012 → May 2019 | plasma cell leukemia, plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01549431 | Jan 2012 → Feb 2016 | plasma cell myeloma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01301807 | Jul 2011 → Nov 2019 | non-secretory plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01336920 | Jun 2011 → Apr 2015 | adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal nasal NK/T cell lymphoma +1 | University of Nebraska | Completed | No outcome recorded |
| Phase 1 | NCT01276717 | Jan 2011 → Jul 2013 | lymphoma | University of Rochester | Completed | No outcome recorded |
| Phase 1 | NCT01212380 | Oct 2010 → Jul 2014 | chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01137747 | Oct 2010 → Aug 2014 | leukemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01204164 | Aug 2010 → Mar 2016 | acute myeloid leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, plasma cell myeloma | Tragara Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00603447 | May 2008 → May 2013 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00150462 | Sep 2005 → Oct 2009 | Hodgkins lymphoma, Waldenstrom macroglobulinemia, plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1/242 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07479979 | May 2026 → Jul 2027 expected | plasma cell myeloma | Natalie Callander | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06892522 | Jun 2025 → Feb 2036 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06055075 | Dec 2023 → Jul 2025 | refractory plasma cell neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT05434689 | Jan 2023 → Aug 2028 expected | plasma cell myeloma | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05017545 | Dec 2021 → Feb 2027 expected | anti-HLA hyperimmunization | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05060627 | Dec 2021 → Oct 2024 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04973605 | Sep 2021 → Nov 2026 expected | refractory plasma cell neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04764942 | May 2021 → May 2026 overdue | plasma cell myeloma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03795597 | May 2019 → Nov 2022 | plasma cell myeloma | Loyola University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02545907 | Sep 2017 → Sep 2019 | amyloidosis | University College, London | Completed | No outcome recorded |
| Phase 1/2 | NCT02802163 | Jun 2017 → Sep 2020 | plasma cell myeloma | H. Lee Moffitt Cancer Center and Research Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02867618 | Oct 2016 → Jun 2020 | Hodgkins lymphoma, non-Hodgkin lymphoma | Columbia University | Terminated | No outcome recorded |
| Phase 1/2 | NCT02773030 | Oct 2016 → May 2024 overdue | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02937571 | Oct 2016 → Oct 2024 | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02343042 | Oct 2015 → Apr 2027 expected | plasma cell myeloma | Karyopharm Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03141203 | Jul 2015 → Aug 2020 | peripheral T-cell lymphoma, not otherwise specified | University of Birmingham | Completed | No outcome recorded |
| Phase 1/2 | NCT02073097 | Jan 2015 → Jul 2021 | diffuse large B-cell lymphoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02341014 | Jan 2015 → Jan 2023 | T-cell non-Hodgkin lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02145403 | Oct 2014 → Nov 2018 | graft versus host disease, hematopoietic and lymphoid cell neoplasm | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02204241 | Jun 2014 → Jun 2015 | plasma cell myeloma | European Myeloma Network B.V. | Completed | No outcome recorded |
| Phase 1/2 | NCT02185820 | Jun 2014 → Jul 2015 | plasma cell myeloma | European Myeloma Network B.V. | Completed | No outcome recorded |
| Phase 1/2 | NCT02056756 | Apr 2014 → Sep 2015 | plasma cell myeloma | Stichting European Myeloma Network | Completed | No outcome recorded |
| Phase 1/2 | NCT01962792 | Dec 2013 → Mar 2019 | plasma cell myeloma | Pharmacyclics LLC. | Completed | No outcome recorded |
| Phase 1/2 | NCT01987232 | Nov 2013 → Aug 2016 | small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT01941316 | Nov 2013 → Dec 2018 | non-small cell lung carcinoma, small cell lung carcinoma | Cancer Research and Biostatistics Clinical Trials Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT02002598 | Nov 2013 → Mar 2019 | plasma cell myeloma | Suzanne Lentzsch, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01842308 | Jun 2013 → Oct 2017 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT01857115 | Apr → Nov 2013 | plasma cell myeloma | European Myeloma Network B.V. | Completed | No outcome recorded |
| Phase 1/2 | NCT01792102 | Apr 2013 → Dec 2018 | plasma cell myeloma | Oncotherapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT01665794 | Aug 2012 → Nov 2025 | plasma cell myeloma | University of Chicago | Completed | Met primary |
| Phase 1/2 | NCT01677858 | Jul 2012 → Jul 2016 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT01658904 | Jul 2012 → Feb 2014 | plasma cell leukemia, plasma cell myeloma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT01246063 | May 2012 → Dec 2017 | plasma cell myeloma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT01690143 | May 2012 → Nov 2017 | plasma cell myeloma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1/2 | NCT01496118 | Dec 2011 → Dec 2020 | plasma cell myeloma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01464034 | Nov 2011 → Jul 2020 | plasma cell myeloma | Criterium, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01365559 | May 2011 → Jun 2014 | plasma cell myeloma | Oncotherapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT01297764 | Apr 2011 → Jul 2026 overdue | plasma cell myeloma | Hackensack Meridian Health | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01279694 | Oct 2010 → Feb 2014 | plasma cell myeloma | Nantes University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01057225 | Mar 2010 → Mar 2014 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT01029054 | Sep 2009 → Dec 2011 | plasma cell myeloma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00531284 | Sep 2007 → Oct 2014 | kidney cancer, non-small cell lung carcinoma, ovarian cancer, plasma cell myeloma +1 | Amgen | Completed | No outcome recorded |
| Phase 283 trials · 7 met primary · 5 missed | ||||||
| Phase 2 | NCT07605416 | Apr 2027 → Nov 2032 expected | plasma cell leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07652879 | Jun 2026 → Jan 2028 expected | POEMS syndrome | Shanghai Changzheng Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07227311 | Apr 2026 → Aug 2030 expected | plasma cell myeloma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT07348393 | Feb 2026 → Feb 2029 expected | refractory plasma cell neoplasm | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06627751 | May 2025 → May 2027 expected | plasma cell myeloma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06158412 | Nov 2023 → Dec 2025 overdue | plasma cell myeloma | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06140966 | Oct 2023 → Oct 2026 expected | plasma cell leukemia, plasma cell myeloma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT05789303 | May 2023 → Jul 2028 expected | plasma cell myeloma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT04933539 | Oct 2022 → Sep 2026 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05497804 | Sep 2022 → Feb 2026 overdue | plasma cell myeloma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04850599 | Jun 2022 → Oct 2027 expected | plasma cell myeloma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04925193 | Nov 2021 → Aug 2024 overdue | plasma cell myeloma | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04892446 | Nov 2021 → Apr 2024 | plasma cell myeloma | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT05509374 | Oct 2021 → Jun 2024 | plasma cell myeloma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT04263480 | Aug 2021 → May 2028 expected | Waldenstrom macroglobulinemia | Christian Buske | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04883242 | Jul 2021 → Dec 2026 expected | plasma cell myeloma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04661137 | Mar 2021 → Feb 2028 expected | plasma cell myeloma | Hackensack Meridian Health | Recruiting | No outcome recorded |
| Phase 2 | NCT04287855 | Aug 2020 → Apr 2025 | plasma cell myeloma | Poitiers University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04191616 | Aug 2020 → Nov 2022 | refractory plasma cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT04430894 | Jul 2020 → Jul 2022 overdue | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | Missed primary |
| Phase 2 | NCT04176718 | May 2020 → May 2027 expected | plasma cell myeloma | Andrew Yee, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04268498 | Feb 2020 → Feb 2027 expected | plasma cell myeloma | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04113018 | Jan 2020 → Jun 2023 overdue | plasma cell myeloma | Wake Forest University Health Sciences | Active not recruiting | Missed primary |
| Phase 2 | NCT03891355 | Sep 2019 → Dec 2020 | mantle cell lymphoma | Fondazione Italiana Linfomi - ETS | Unknown | No outcome recorded |
| Phase 2 | NCT03606577 | Jul 2019 → Feb 2022 overdue | plasma cell myeloma | Nantes University Hospital | Active not recruiting | Met primary |
| Phase 2 | NCT03815279 | Jun 2019 → Jan 2024 overdue | smoldering plasma cell myeloma | Landspitali University Hospital | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT03500445 | Feb 2019 → Jun 2026 overdue | plasma cell myeloma | University of Chicago | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03756896 | Jan 2019 → Jun 2025 overdue | plasma cell myeloma | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03673826 | Nov 2018 → Aug 2024 overdue | smoldering plasma cell myeloma | HOVON Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03512353 | Jul 2018 → Jan 2020 | refractory plasma cell neoplasm | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03556332 | Jul 2018 → Jul 2027 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03289299 | May 2018 → Sep 2023 overdue | smoldering plasma cell myeloma | International Myeloma Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04065789 | May 2018 → Aug 2021 | plasma cell myeloma | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03412565 | Apr 2018 → Aug 2020 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT03314636 | Mar 2018 → Nov 2021 overdue | plasma cell myeloma | Oslo University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03224507 | Mar 2018 → May 2023 | plasma cell myeloma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03256045 | Feb 2018 → Feb 2021 | plasma cell myeloma | University of Washington | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03336073 | Dec 2017 → Dec 2024 | plasma cell myeloma | PETHEMA Foundation | Unknown | Missed primary |
| Phase 2 | NCT03269552 | Dec 2017 → Dec 2018 | Waldenstrom macroglobulinemia, marginal zone lymphoma | University of Washington | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03290950 | Sep 2017 → May 2025 overdue | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03140943 | Sep 2017 → Jun 2019 | refractory plasma cell neoplasm | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT03104842 | Aug 2017 → May 2026 overdue | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Active not recruiting | Met primary |
| Phase 2 | NCT03155100 | Aug 2017 → Aug 2023 | plasma cell myeloma | Raija Silvennoinen | Completed | No outcome recorded |
| Phase 2 | NCT02969837 | Jul 2017 → Oct 2021 | plasma cell myeloma | University of Chicago | Completed | Met primary |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03104270 | Mar 2017 → Oct 2019 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02891811 | Mar 2017 → Mar 2024 | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Completed | No outcome recorded |
| Phase 2 | NCT02899052 | Jan 2017 → Jun 2027 expected | plasma cell myeloma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02597062 | Jul 2016 → Jun 2019 | plasma cell myeloma | Canadian Cancer Trials Group | Completed | No outcome recorded |
| Phase 2 | NCT02491359 | Nov 2015 → Feb 2018 | chronic graft versus host disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02474927 | Nov 2015 → Nov 2020 | transplant rejection | John F. McDyer, MD | Completed | No outcome recorded |
| Phase 2 | NCT02318784 | Jul 2015 → May 2021 | neuroendocrine neoplasm | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02315716 | Jun 2015 → Nov 2019 overdue | plasma cell myeloma | University College, London | Active not recruiting | Missed primary |
| Phase 2 | NCT02415413 | May 2015 → Jul 2018 overdue | smoldering plasma cell myeloma | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02203643 | Feb 2015 → Oct 2016 | plasma cell myeloma | Mario Boccadoro | Completed | Met primary |
| Phase 2 | NCT02572492 | Jan 2015 → Apr 2018 | plasma cell myeloma | Henrik Gregersen | Unknown | No outcome recorded |
| Phase 2 | NCT02294357 | Dec 2014 → Sep 2020 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02217163 | Oct 2014 → Oct 2020 | plasma cell myeloma | Singapore General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02114502 | Sep 2014 → Sep 2018 | plasma cell myeloma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02042950 | Jul 2014 → Dec 2017 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02128230 | Jun 2014 → Feb 2019 | plasma cell myeloma | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02047253 | Apr 2014 → Jun 2017 | castration-resistant prostate carcinoma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT02405364 | Feb 2014 → Nov 2019 | plasma cell myeloma | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 2 | NCT02302495 | Jan 2014 → Jul 2016 | plasma cell myeloma | University Hospital, Lille | Completed | No outcome recorded |
| Phase 2 | NCT01989325 | Nov 2013 → Feb 2016 | plasma cell myeloma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01903811 | Oct 2013 → Nov 2017 | plasma cell myeloma | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 2 | NCT01775930 | Oct 2013 → Jan 2019 | kidney cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02020941 | Sep 2013 → Jan 2016 | plasma cell myeloma | Attaya Suvannasankha | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01775553 | Sep 2013 → May 2016 | plasma cell myeloma | Ajai Chari | Completed | No outcome recorded |
| Phase 2 | NCT01969565 | Aug 2013 → Oct 2014 | plasma cell myeloma | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT01812720 | Aug 2013 → Sep 2014 | plasma cell myeloma | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 2 | NCT01813227 | Apr 2013 → Sep 2014 | Waldenstrom macroglobulinemia | Hackensack Meridian Health | Completed | No outcome recorded |
| Phase 2 | NCT01816971 | Jan 2013 → Apr 2018 | plasma cell myeloma | University of Chicago | Completed | Met primary |
| Phase 2 | NCT01572480 | May 2012 → Mar 2022 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01559935 | Apr 2012 → Jun 2016 | plasma cell myeloma | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT01470196 | Oct 2011 → Sep 2016 | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01402284 | Jul 2011 → Jul 2016 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT01346787 | Jul 2011 → Oct 2012 | plasma cell myeloma | European Myeloma Network B.V. | Completed | No outcome recorded |
| Phase 2 | NCT01351623 | May 2011 → Jan 2016 | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00884312 | Apr 2009 → May 2017 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00721734 | Nov 2008 → Nov 2012 | impaired renal function disease, plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00530816 | Sep 2007 → Jan 2013 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00511238 | Aug 2007 → Nov 2010 | plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06879379 | Mar 2025 → Mar 2028 expected | plasma cell myeloma | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04513639 | Aug 2020 → Jun 2031 expected | plasma cell myeloma | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 316 trials · 9 met primary · 3 missed | ||||||
| Phase 3 | NCT07222761 | Jan 2026 → May 2029 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06158841 | May 2024 → Dec 2027 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05572515 | Mar 2023 → Oct 2025 overdue | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05552976 | Jan 2023 → Sep 2026 overdue | refractory plasma cell neoplasm | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT04096066 | Jul 2019 → Sep 2027 expected | plasma cell myeloma | Fondazione EMN Italy Onlus | Active not recruiting | Met primary |
| Phase 3 | NCT03729804 | May 2019 → Dec 2026 expected | plasma cell myeloma | University of Chicago | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03651128 | Apr 2019 → Apr 2026 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT03742297 | Oct 2018 → Jul 2023 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | Met primary |
| Phase 3 | NCT03029234 | Mar 2017 → Nov 2018 | refractory plasma cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02659293 | Apr 2016 → Nov 2027 expected | plasma cell myeloma | University of Chicago | Active not recruiting | Met primary |
| Phase 3 | NCT02412878 | Sep 2015 → Jun 2017 | plasma cell myeloma | Amgen | Completed | Met primary |
| Phase 3 | NCT01863550 | Dec 2013 → Dec 2026 expected | plasma cell myeloma | ECOG-ACRIN Cancer Research Group | Active not recruiting | Missed primary |
| Phase 3 | NCT01818752 | Jul 2013 → Jul 2016 | plasma cell myeloma | Amgen | Completed | Missed primary |
| Phase 3 | NCT01568866 | Jun 2012 → Nov 2014 | plasma cell myeloma | Amgen | Completed | Met primary |
| Phase 3 | NCT01302392 | Sep 2010 → Jul 2014 | plasma cell myeloma | Amgen | Completed | Missed primary |
| Phase 3 | NCT01080391 | Jul 2010 → Jun 2014 | plasma cell myeloma | Amgen | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07709884 | Jul 2026 → Dec 2028 expected | plasma cell myeloma | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06409702 | Jun 2024 → Nov 2027 expected | plasma cell myeloma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 4 | NCT03934684 | Sep 2019 → Mar 2023 | refractory plasma cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT00999414 | Nov 2009 → Apr 2015 | plasma cell myeloma | University of Arkansas | No longer available | No outcome recorded |
| — | NCT01410500 | — | plasma cell myeloma | Amgen | Approved for marketing | No outcome recorded |
| Comparator or background therapy45 trials | ||||||
| Phase 0 | NCT01537861 Background | Jun 2012 → Feb 2014 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT07082270 Background | Apr 2026 → Feb 2028 | plasma cell myeloma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT06622005 Background | Apr 2025 → Apr 2027 expected | plasma cell myeloma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT04813653 Background | Apr 2021 → Mar 2025 | plasma cell myeloma, refractory plasma cell neoplasm | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT04163107 Background | Jan 2020 → Dec 2021 | plasma cell myeloma | Norwegian University of Science and Technology | Completed | No outcome recorded |
| Phase 1 | NCT03031730 Background | Jun 2018 → Jul 2024 | plasma cell myeloma, plasmacytoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02148913 Comparator | Jun 2014 → Dec 2018 | plasma cell myeloma | Corewell Health West | Completed | No outcome recorded |
| Phase 1 | NCT01998971 Background | Feb 2014 → Jan 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02036502 Background | Feb 2014 → Mar 2020 | plasma cell myeloma | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT07463807 Comparator | Jul → Aug 2026 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05199311 Background | May 2022 → Mar 2027 | plasma cell myeloma | Hackensack Meridian Health | Suspended | No outcome recorded |
| Phase 1/2 | NCT04822337 Background | May 2021 → Apr 2029 expected | plasma cell myeloma | Wake Forest University Health Sciences | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03989414 Background | Sep 2019 → Nov 2026 expected | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03773107 Background | Jan 2019 → Nov 2022 | plasma cell myeloma | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT02265510 Background | Sep 2014 → Feb 2019 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT06948084 Comparator | May 2027 → Feb 2028 expected | plasma cell myeloma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06356571 Background | Mar 2025 → Jan 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT05896228 Background | Feb 2024 → Mar 2029 expected | plasma cell myeloma | Benjamin T Diamond, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05909826 Background | Jul 2023 → Jun 2027 expected | plasma cell myeloma | Dong-A University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05704049 Background | Apr 2023 → Dec 2025 overdue | refractory plasma cell neoplasm | Sanofi | Active not recruiting | Met primary |
| Phase 2 | NCT05669989 Background | Apr 2023 → Nov 2026 expected | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04756401 Background | Dec 2022 → Aug 2025 overdue | plasma cell myeloma | Academic and Community Cancer Research United | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03871829 Background | May 2019 → Oct 2022 | plasma cell myeloma | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 2 | NCT03805178 Background | May 2019 → Aug 2020 | transplant rejection | Duke University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03004287 Background | Jul 2017 → Oct 2027 expected | plasma cell myeloma | University of Arkansas | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02756663 Background | Dec 2016 → Feb 2021 | plasma cell myeloma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT02628704 Background | Dec 2015 → Jun 2017 | plasma cell myeloma | Karyopharm Therapeutics Inc | Withdrawn | No outcome recorded |
| Phase 2 | NCT02188368 Background | Jul 2014 → Oct 2020 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07555938 Comparator | Jun 2026 → Oct 2028 expected | plasma cell myeloma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT07391657 Comparator | Feb 2026 → Jun 2028 expected | refractory plasma cell neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06615479 Background | Mar 2025 → Dec 2027 expected | refractory plasma cell neoplasm | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06413498 Comparator | Aug 2024 → Jul 2028 expected | plasma cell myeloma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06232707 Comparator | May 2024 → Nov 2025 | plasma cell myeloma | Celgene Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06152575 Comparator | Feb 2024 → Aug 2026 overdue | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05675319 Comparator | Mar 2023 → Mar 2025 | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05438043 Background | Dec 2022 → Jan 2029 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04483739 Background | Sep 2020 → Jul 2025 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | Met primary |
| Phase 3 | NCT04288765 Background | Mar 2020 → Dec 2024 | plasma cell myeloma | Grupo Cooperativo de Hemopatías Malignas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03859427 Comparator | May 2019 → Mar 2023 | refractory plasma cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03948035 Background | Aug 2018 → Aug 2029 expected | plasma cell myeloma | Wuerzburg University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03275285 Background | Oct 2017 → Jan 2022 | plasma cell myeloma | Sanofi | Completed | Met primary |
| Phase 3 | NCT03158688 Background | Jun 2017 → Jul 2019 | plasma cell myeloma | Amgen | Completed | Met primary |
| Phase 3 | NCT01554852 Comparator | May 2010 → Dec 2021 | plasma cell myeloma | University of Leeds | Unknown | No outcome recorded |
| Phase 4 | NCT03416374 Background | Feb 2018 → May 2021 | refractory plasma cell neoplasm | Takeda | Completed | No outcome recorded |
| — | NCT06793475 Background | Apr 2025 → Jun 2026 overdue | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 83
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM). |
| 2026-05-29 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces CELMoD Mezigdomide Reduces Risk of Disease Progression or Death by More than 50% vs. Standard of Care in Relapsed or Refractory Multiple Myeloma bms.com ↗
Results showed MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd. |
| 2025-06-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Data Across Targeted Protein Degradation Research Including CELMoD™ Agents and BCL6 Ligand-Directed Degrader at EHA 2025 bms.com ↗
Updated results were presented from the dose-escalation phase of the MM-002 study for the combinations of mezigdomide, dexamethasone, and bortezomib (Cohort A MeziVd; n=28), and mezigdomide, dexamethasone, and carfilzomib (Cohort C MeziKd; n=27) |
| 2025-06-03 | Sanofi | Results Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector sanofi.com ↗
ORR was 79.7% in patients treated with Sarclisa SC-Kd (95% CI: 68.8-88.2) validating the prespecified efficacy hypothesis. |
| 2025-05-22 | Regeneron Pharmaceuticals | Results Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple myeloma (MM). |
| 2024-12-05 | Pfizer | Results Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS pfizer.com ↗
Data will also be shared from the ongoing Phase 1b MagnetisMM-20 trial that indicate encouraging clinical efficacy and predictable safety signals with ELREXFIO in combination with carfilzomib and dexamethasone after a median of two prior lines of therapy (range: one to three). |
| 2023-12-11 | Sanofi | Results Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone sanofi.com ↗
Phase 3 data showed Sarclisa added to carfilzomib, lenalidomide and dexamethasone (KRd) in patients with newly diagnosed, transplant-eligible multiple myeloma resulted in 77% of patients achieving minimal residual disease (MRD) negativity after consolidation therapy, detected with a sensitivity of 10 -5 |
| 2023-12-08 | Amgen | Results AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023 amgen.com ↗
New Data Reinforce KYPROLIS ® (carfilzomib) as an Important Treatment Option for Relapsed or Refractory Multiple Myeloma |
| 2023-01-18 | BeOne Medicines | Regulatory BeiGene Announces Expansion of Coverage on China’s National Reimbursement Drug List beonemedicines.com ↗
KYPROLIS® (carfilzomib), a proteosome inhibitor licensed-in from Amgen, is included for the first time and XGEVA® (denosumab), a RANKL inhibitor and another Amgen asset, successfully renewed this year. |
| 2022-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm Announces New Selinexor Data in Myelofibrosis and Multiple Myeloma to be Presented at ASH 2022 karyopharm.com ↗
The presentations include results from the Phase 1 open-label, dose-escalation study of selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (MF) and data from a subset analysis of the STOMP study in patients with triple-class refractory MM. |
| 2022-05-15 | Sanofi | Results Press Release: Sarclisa® (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy sanofi.com ↗
The median progression free survival, increased from 19.2 months to 35.7 months when Sarclisa was added to carfilzomib and dexamethasone |
| 2021-12-01 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves DARZALEX FASPRO® (daratumumab and hyaluronidasefihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗ |
| 2021-12-01 | Amgen | Regulatory FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone For Patients With Multiple Myeloma At First Or Subsequent Relapse amgen.com ↗ |
| 2021-12-01 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse halozyme.com ↗ |
| 2021-07-09 | BeOne Medicines | Regulatory BeiGene Announces the Approval in China of KYPROLIS® (Carfilzomib) for Injection for Adult Patients with Relapsed or Refractory Multiple Myeloma beonemedicines.com ↗
This is the first approval for KYPROLIS in China. |
| 2021-06-14 | NATCO Pharma Ltd. | Regulatory NATCO receives approval for Carfilzomib Vials ANDA (generic for KYPROLIS® ) in the US market natcopharma.co.in ↗
The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. |
| 2021-05-19 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the 2021 American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
In 27 patients with heavily pretreated MM (median of 4 lines of prior therapy), weekly XKd is highly active wi |
| 2021-04-19 | Sanofi | Regulatory European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma sanofi.com ↗
Today, the European Commission (EC) approved Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. |
| 2021-03-31 | Sanofi | Regulatory FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. |
| 2021-02-26 | Sanofi | Regulatory Media Update: CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma sanofi.com ↗
CHMP recommends approval of Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma |
| 2020-08-24 | Ligand Pharmaceuticals | Regulatory Ligand Announces Amgen’s KYPROLIS® Approved by FDA as Combination Regimen with DARZALEX® and Dexamethasone in Once- and Twice-Weekly Dosing Regimens for Patients with Relapsed/Refractory Multiple Myeloma ligand.com ↗ |
| 2020-08-21 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
first-ever approval of an anti-CD38 with carfilzomib |
| 2020-08-20 | Amgen | Regulatory FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone In Both Once- And Twice-Weekly Dosing Regimens amgen.com ↗ |
| 2020-06-02 | Sanofi | Results Sarclisa® (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma sanofi.com ↗
Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) alone |
| 2020-05-29 | Oncolytics Biotech | Results Oncolytics Biotech® Presents Clinical Proof-of-Concept Data in Multiple Myeloma at the ASCO Virtual Annual Meeting oncolyticsbiotech.com ↗
Data presented in the ePoster demonstrates that the pelareorep-carfilzomib combination treatment results in selective replication of pelareorep in cancer cells and beneficial induction of an inflamed tumor environment associated with clinical responses. |
| 2020-05-14 | Oncolytics Biotech | Results Oncolytics Biotech® Announces Publication of Abstracts at the 2020 American Society of Clinical Oncology Virtual Annual Meeting oncolyticsbiotech.com ↗
Clinical response was associated with tumor-specific replication, PD-L1 upregulation, and CD8+ cell recruitment in multiple myeloma patients treated with pelareorep and carfilzomib |
| 2019-12-10 | Janssen Research & Development, LLC | Results DARZALEX® (Daratumumab) Regimen Shows Significant Increase in Progression-Free Survival in Treatment of Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
Results from the CANDOR study showed that, compared to Kd alone, DKd resulted in significantly longer PFS rates and response rates. |
| 2019-12-10 | Amgen | Results Amgen Data From Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) To Be Presented During Late-Breaking Session At American Society Of Hematology Annual Meeting amgen.com ↗
Median PFS was not reached for the KdD arm versus 15.8 months for the Kd arm. |
| 2019-12-09 | Oncolytics Biotech | Results Oncolytics Biotech(R) Announces Positive Multiple Myeloma Data Presented at the 61st Annual Meeting & Exposition of the American Society of Hematology oncolyticsbiotech.com ↗
Oncolytics Biotech ® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation was given over the weekend highlighting pre-clinical and clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. |
| 2019-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Presents XPOVIO® (Selinexor) and Eltanexor Data at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
The Kyprolis arm of the STOMP study continues to show clear signs of clinical activity, including a complete response rate of 21%, in patients with heavily pretreated Kyprolis-naïve multiple myeloma. |
| 2019-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Reports New and Updated XPOVIO® (Selinexor) Data in Relapsed or Refractory Multiple Myeloma at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
Although these data are early, six of seven patients whose disease relapsed after CAR-T achieved a response when treated with selinexor and dexamethasone alone or in combination with either Velcade® (bortezomib) or Kyprolis® (carfilzomib). |
| 2019-11-07 | Oncolytics Biotech | Results Oncolytics Biotech(R) Announces Abstract Published for the 61st Annual Meeting & Exposition of the American Society of Hematology oncolyticsbiotech.com ↗
Oncolytics Biotech ® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an abstract highlighting the pre-clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. |
| 2019-11-06 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO® (Selinexor) Clinical Data to be Presented at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
In both arms the response rates and safety profile remain highly encouraging. |
| 2019-09-13 | Amgen | Results Amgen Announces Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) Meets Primary Endpoint Of Progression-Free Survival amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study evaluating KYPROLIS ® (carfilzomib) in combination with dexamethasone and DARZALEX ® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) met its primary endpoint of progression-free survival (PFS). |
| 2019-06-14 | Karyopharm Therapeutics Inc | Results Karyopharm Reports New and Updated Selinexor Combination Data from the Phase 1b/2 STOMP Study at the European Hematology Association 2019 Annual Meeting karyopharm.com ↗
Preliminary data from the Kyprolis arm of the Phase 1b/2 STOMP study show early but encouraging clinical activity, including two patients who achieved a complete response |
| 2018-12-03 | Oncolytics Biotech | Results Oncolytics Biotech® Announces Increased PD-L1 Expression When Combining Pelareorep with a Proteasome Inhibitor in Poster Presentation at the 60th American Society of Hematology Annual Meeting & Exposition oncolyticsbiotech.com ↗
The data in this poster clearly demonstrate an increase in viral infection and viral replication, as well as pelareorep-dependent PD-L1 increased expression on the surface of myeloma cells, among patients undergoing treatment with pelareorep in combination with carfilzomib. |
| 2018-11-01 | Oncolytics Biotech | Results Oncolytics Biotech® Announces Abstract for ASH Annual Meeting & Exposition Demonstrating Pelareorep Increases PD-L1 Expression When Combined with a Proteasome Inhibitor oncolyticsbiotech.com ↗
In part one of the study, six carfilzomib-sensitive patients showed reovirus infection and replication in the post-treatment bone marrow aspirates. |
| 2018-10-01 | Amgen | Regulatory FDA Approves KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma amgen.com ↗ |
| 2018-08-27 | Amgen | Regulatory Amgen Submits Supplemental New Drug Application For KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone amgen.com ↗ |
| 2018-06-11 | Amgen | Regulatory FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS® (carfilzomib) Label amgen.com ↗
With this approval, the U.S. Prescribing Information for KYPROLIS now includes positive overall survival data from two Phase 3 trials, underscoring the important role of proteasome inhibition in the treatment of multiple myeloma. |
| 2018-06-01 | Amgen | Results Phase 3 A.R.R.O.W. Interim Analysis Shows Once-Weekly 70 mg/m2 KYPROLIS® (carfilzomib) Regimen Significantly Extended Progression-Free Survival Versus A Twice-Weekly 27 mg/m2 Regimen In Patients With Relapsed And Refractory Multiple Myeloma amgen.com ↗
Amgen (NASDAQ:AMGN) today announced results from the Phase 3 A.R.R.O.W. trial of a once-weekly KYPROLIS ® (carfilzomib) dosing regimen in patients with relapsed and refractory multiple myeloma. |
| 2018-04-30 | Amgen | Regulatory Amgen Receives Positive CHMP Opinion To Add Overall Survival Results From The Phase 3 ASPIRE Study To KYPROLIS® (carfilzomib) Label amgen.com ↗ |
| 2018-01-30 | Amgen | Regulatory Amgen Receives CHMP Positive Opinion To Add Updated Overall Survival Data To KYPROLIS® (carfilzomib) Label amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for KYPROLIS ® (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade ® [bortezomib] and dexamethasone [Vd]). |
| 2018-01-17 | Amgen | Results Overall Survival Analysis From KYPROLIS® (Carfilzomib) Phase 3 ASPIRE Trial Published in the Journal of Clinical Oncology amgen.com ↗
Furthermore, these data showed that early use of carfilzomib, lenalidomide and dexamethasone at first relapse provided nearly one additional year of survival for patients regardless of prior treatment with bortezomib or transplant. |
| 2018-01-17 | Amgen | Regulatory FDA Approves Addition Of Overall Survival Data To KYPROLIS® (carfilzomib) Label amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS ® (carfilzomib). |
| 2017-12-11 | Amgen | Results KYPROLIS® (carfilzomib) Extended Overall Survival In Patients With Relapsed Or Refractory Multiple Myeloma In Phase 3 ASPIRE Trial amgen.com ↗
Results from the ASPIRE trial are among the first to show a significant overall survival advantage resulting from adding carfilzomib to lenalidomide and dexamethasone treatment in patients with relapsed or refractory multiple myeloma. |
| 2017-12-07 | Amgen | Results New Data To Be Presented At ASH 2017 Underscore Amgen's Commitment To Improving Lives And Changing Outcomes For Patients With Difficult-To-Treat Blood Cancers amgen.com ↗
Notably at ASH, positive overall survival (OS) results from the Phase 3 ASPIRE trial will be detailed for the first time in an oral presentation, which showed the addition of KYPROLIS ® (carfilzomib) to lenalidomide and dexamethasone (KRd) significantly extended OS versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma. |
| 2017-10-23 | Amgen | Results Phase 3 A.R.R.O.W. Study Of Once-Weekly KYPROLIS® (Carfilzomib) Regimen Meets Primary Endpoint Of Progression-Free Survival In Relapsed And Refractory Multiple Myeloma Patients amgen.com ↗ |
| 2017-08-30 | Amgen | Results Long-Term Analysis Of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival In Patients With Relapsed Multiple Myeloma amgen.com ↗
Kd reduced the risk of death by 24 percent over Vd (median OS 47.8 months for Kd versus 38.8 months for Vd, HR=0.76, 95 percent CI, 0.63-0.92; p =0.0017). |
| 2017-08-30 | Amgen | Regulatory FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS® (Carfilzomib) Label amgen.com ↗ |
| 2017-08-23 | Amgen | Results Overall Survival Analysis From KYPROLIS® (carfilzomib) Phase 3 Endeavor Trial Published In The Lancet Oncology amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that results from an overall survival (OS) analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology. |
| 2017-07-14 | Amgen | Regulatory Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival Data In KYPROLIS® (Carfilzomib) Label amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS ® (carfilzomib). |
| 2017-07-12 | Amgen | Results Second Phase 3 Study Shows KYPROLIS® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma amgen.com ↗
The study met the key secondary endpoint of overall survival (OS), demonstrating that KYPROLIS ® (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95). |
| 2017-06-21 | Amgen | Results Amgen To Present New Data At 22nd Congress of the European Hematology Association amgen.com ↗
KYPROLIS ® is the first-and-only multiple myeloma therapy to demonstrate superior overall survival in a head-to-head comparison with a current standard of care, extending survival by 7.6 months over Velcade ® (bortezomib). |
| 2017-03-03 | Amgen | Results Amgen Presents Overall Survival Data From KYPROLIS® (carfilzomib) Phase 3 ENDEAVOR Trial At 16th International Myeloma Workshop amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial. |
| 2017-03-01 | Amgen | Results Amgen To Present New KYPROLIS® (Carfilzomib) And XGEVA® (Denosumab) Data At The 16th International Myeloma Workshop amgen.com ↗
Detailed results will be presented from the Phase 3 ENDEAVOR study which showed that KYPROLIS improved OS in patients with relapsed or refractory multiple myeloma. |
| 2017-02-28 | Amgen | Results Phase 3 Head-to-Head Trial Showed KYPROLIS® (Carfilzomib) Significantly Improved Overall Survival Compared To Velcade® (Bortezomib) In Relapsed Or Refractory Multiple Myeloma Patients amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial. |
| 2016-12-05 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Phase 1b STOMP Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗
Other key presentations at the meeting described clinical data demonstrating the activity of selinexor in combination with carfilzomib (Kyprolis®) and pomalidomide (Pomalyst®) in MM, as well as selinexor with dexamethasone in quad- and penta-refractory MM in the STORM trial. |
| 2016-09-27 | Amgen | Results Amgen Announces Top-Line Results From Phase 3 KYPROLIS® (Carfilzomib) CLARION Study In Newly Diagnosed Multiple Myeloma Patients amgen.com ↗
The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). |
| 2016-07-03 | Amgen | Regulatory European Commission Approves Extended Indication For Amgen's Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma Patients amgen.com ↗
The EC approved the extended indication for Kyprolis based on data from the Phase 3 head-to-head ENDEAVOR trial in which patients with multiple myeloma treated with Kyprolis plus dexamethasone (Kd) achieved superior progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone (Vd) (HR=0.53; 95 percent CI: 0.44, 0.65; p <0.0001). |
| 2016-06-10 | Amgen | Results New Analyses From Pivotal Phase 3 Studies Show Kyprolis® (Carfilzomib) Allows Patients With Relapsed Multiple Myeloma To Live Longer Without Disease Progression amgen.com ↗
Amgen (NASDAQ:AMGN) today announced results from a post-hoc analysis of the pivotal Phase 3 ASPIRE study which highlighted the benefit of continued treatment with Kyprolis ® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. |
| 2016-06-06 | Amgen | Results New Phase 3 Secondary Analysis Shows Progression-Free Survival Benefit In Early Relapsing Multiple Myeloma Patients Treated With Kyprolis® (Carfilzomib)-Based Regimen amgen.com ↗
The analysis showed that patients relapsing within one year of initial therapy treated with KRd (n=87) experienced a median PFS of 24.1 months versus 12.5 months in those treated with Rd (n=72) (HR=0.75; 95 percent CI: 0.50-1.13). |
| 2016-05-27 | Amgen | Regulatory Amgen Receives Positive CHMP Opinion To Extend Indication Of Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma amgen.com ↗
We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis. |
| 2016-01-21 | Amgen | Regulatory FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma amgen.com ↗
The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. |
| 2015-12-08 | Oncolytics Biotech | Results Oncolytics Biotech® Inc. Collaborators Present Multiple Myeloma Data at 57th American Society of Hematology Annual Meeting oncolyticsbiotech.com ↗ |
| 2015-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Positive Clinical Data on the Activity of Selinexor in Combination with Other Anticancer Agents across Multiple Hematologic Malignancies at the 2015 American Society of Hematology (ASH) Annual Meeting karyopharm.com ↗
including carfilzomib and dexamethasone in refractory multiple myeloma |
| 2015-12-06 | AbbVie | Results Ibrutinib (IMBRUVICA®) Combination Data Show Promise in Patients with Relapsed/Refractory Multiple Myeloma abbvie.com ↗
Thirty-nine patients were evaluable for efficacy and demonstrated a 62% ORR during early follow-up, with a clinical benefit rate (CBR) of 72%. |
| 2015-12-05 | Amgen | Results Pivotal Head-To-Head ENDEAVOR Study Results Published in The Lancet Oncology Demonstrate Superiority of Kyprolis® (carfilzomib) Combination Over Velcade® (bortezomib) Combination amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that The Lancet Oncology published results from the pivotal Phase 3 head-to-head ENDEAVOR study comparing Kyprolis ® (carfilzomib) plus dexamethasone to Velcade ® (bortezomib) plus dexamethasone in patients with relapsed multiple myeloma. |
| 2015-12-05 | Amgen | Results New Analyses Presented At ASH 2015 Demonstrate The Potential Of Kyprolis® (Carfilzomib) As Backbone Therapy In Multiple Myeloma amgen.com ↗
The data showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to bortezomib plus dexamethasone across a range of difficult-to-treat populations, specifically those with high risk and previously treated disease. |
| 2015-12-05 | Amgen | Regulatory Amgen Submits Application In Europe To Expand Indication Of Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indication for Kyprolis ® (carfilzomib) in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| 2015-11-19 | Amgen | Regulatory European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma amgen.com ↗
Amgen (NASDAQ: AMGN) today announced the European Commission (EC) granted marketing authorization for Kyprolis ® (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| 2015-09-25 | Amgen | Regulatory Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe amgen.com ↗
adopted positive opinions recommending marketing authorization for: Kyprolis ® (carfilzomib) in combination with lenalidomide and dexamethasone |
| 2015-09-25 | Oncolytics Biotech | Results Oncolytics Biotech® Inc. Collaborators Present Data from Clinical Study in Multiple Myeloma oncolyticsbiotech.com ↗
100% of patients (8 of 8) experienced an objective response as measured by changes in blood monoclonal protein. |
| 2015-09-18 | Amgen | Regulatory FDA Grants Priority Review for Amgen's Supplemental New Drug Application for Expanded Labeling of Kyprolis® (Carfilzomib) in Relapsed Multiple Myeloma amgen.com ↗
Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration ( FDA ) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis ® (carfilzomib) for Injection for patients with relapsed multiple myeloma. |
| 2015-07-24 | Amgen | Regulatory FDA Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) approved the supplemental New Drug Application (sNDA) for Kyprolis ® (carfilzomib) for Injection in combination with Revlimid ® (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy. |
| 2015-07-23 | Amgen | Regulatory Amgen Submits Supplemental New Drug Application For Kyprolis® (Carfilzomib) In Relapsed Multiple Myeloma amgen.com ↗
Submission of this new sNDA for Kyprolis is important because if approved, it will mean more treatment options for patients with this serious disease. |
| 2015-03-30 | Amgen | Regulatory FDA Grants Amgen Priority Review for Kyprolis® (Carfilzomib) Supplemental New Drug Application for the Treatment of Relapsed Multiple Myeloma amgen.com ↗
As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2015 . |
| 2015-03-02 | Amgen | Results Phase 3 Head-to-Head ENDEAVOR Study Demonstrates Superiority Of Kyprolis® (carfilzomib) Over Velcade® (bortezomib) In Patients With Relapsed Multiple Myeloma amgen.com ↗
Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median PFS 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65). |
| 2015-02-26 | Amgen | Regulatory Amgen Announces The European Medicines Agency Acceptance Of Kyprolis® (Carfilzomib) Marketing Authorization Application For The Treatment Of Relapsed Multiple Myeloma amgen.com ↗
The MAA has been granted accelerated assessment by the EMA. |
| 2015-01-27 | Amgen | Regulatory Amgen Submits Applications In The US And Europe For Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma amgen.com ↗ |
| 2014-12-06 | Amgen | Results Amgen And Onyx Announce Detailed Results From Phase 3 ASPIRE Study Of Kyprolis® (Carfilzomib) In Patients With Relapsed Multiple Myeloma amgen.com ↗
Secondary endpoints, which are being presented for the first time, included overall survival (OS), overall response rate (ORR), duration of response (DOR), health-related quality of life (HR-QoL) measures and safety. |
| 2014-04-07 | Oncolytics Biotech | Results Oncolytics Biotech Inc. Collaborators to Present Preclinical Research in Multiple Myeloma and Melanoma at AACR 2014 Annual Meeting oncolyticsbiotech.com ↗
The poster presents findings demonstrating that reovirus acts synergistically with carfilzomib and/or perifosine in oncolysis of therapy resistant multiple myeloma cell lines. |
| 2012-07-20 | Ligand Pharmaceuticals | Regulatory Ligand Licensee Onyx Pharmaceuticals Receives FDA Accelerated Approval of Kyprolis™ (carfilzomib) for Injection ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its licensee, Onyx Pharmaceuticals (Nasdaq: ONXX), received accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis™ (carfilzomib) for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. |
All press releases naming this drug 93 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 243 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Carfilzomib | “induction therapy using the combination of dexamethasone, lenalidomide (revlimid), daratumumab (Darzalex) and carfilzomib (Kyprolis) to treat patients with newly diagnosed...” NCT03224507 ↗241“Carfilzomib combined with cyclosporine and methotrexate for the prevention of graft-versus-host disease after allogeneic stem-cell transplantation from unrelated donors.” PMID 32873915 ↗ Sep 2020 “Carfilzomib is a selective PI that irreversibly binds the proteasome, eliciting antimyeloma activity through unfolded protein stress response and other mechanisms.” NCT07348393 ↗ “Proteasome inhibitor: Carfilzomib 27mg/m2 2 consecutive days per week x 3 weeks (20mg/m2 on day 1 and day 2 of cycle 1);” NCT06158412 ↗ “four 28-day cycles of carfilzomib (56 mg/m2 intravenously on days 1, 2, 8, 9, 15, and 16)” PMID 36529145 ↗ Dec 2022 “Induction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21” NCT04288765 ↗ “proteasome inhibitor (bortezomib or carfilzomib)” NCT02188368 ↗ “Carboplatin, Carfilzomib, Carmustine” NCT02788201 ↗ “Cabozantinib Carfilzomib Ceritinib” NCT02551718 ↗ “Carfilzomib (Kyprolis®)” NCT02128230 ↗ |
| Known as | CAR | “The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).” NCT03155100 ↗ |
| Known as | Carfilzomib (KYPROLIS) | “Carfilzomib (KYPROLIS®)” NCT05651932 ↗3“Carfilzomib (Kyprolis®)” NCT02128230 ↗ “Carfilzomib (Kyprolis)” NCT01297764 ↗ “Carfilzomib - Kyprolis” NCT02148913 ↗ |
| Known as | Carfilzomib Injection | “Drug: Carfilzomib Injection” NCT04163107 ↗ |
| Known as | CFZ | “CFZ (carfilzomib) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).” NCT02188368 ↗3“Carfilzomib (CFZ) is a newer proteasome inhibitor with increased activity and a safer toxicity profile than bortezomib in PCM.” NCT01658904 ↗ “Carfilzomib (CFZ), a second-generation irreversible 20S core particle proteasome inhibitor” NCT07715903 ↗ “Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd)” NCT03651128 ↗ |
| Known as | Kyprolis | “A Multicenter Phase 1/2b Study of the Bruton's Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or...” NCT01962792 ↗4“KRdD = Kyprolis (Carfilzomib), Revlimid (Lenalidomide), dexamethasone, Darzalex (Daratumumab)” NCT03224507 ↗ “Drug: Carfilzomib (KYPROLIS®): IV, once weekly for 3 weeks in each 28-day cycle” NCT05651932 ↗ “Carfilzomib 56 MG [Kyprolis]” NCT05509374 ↗ “carfilzomib (Kyprolis®)” NCT05060627 ↗ |
| Known as | Kyprolis (carfilzomib) | “Kyprolis (carfilzomib)” NCT01554852 ↗ |
| Known as | Kyprolis (carfilzomib) for Injection | “Kyprolis® (carfilzomib) for Injection” NCT01980589 ↗6“Kyprolis® (carfilzomib) for Injection” NCT02303821 ↗ “Kyprolis® (carfilzomib) for Injection” NCT01949545 ↗ “Kyprolis® (carfilzomib) for Injection” NCT02412878 ↗ “Kyprolis® (carfilzomib) for Injection” NCT00530816 ↗ “Kyprolis® (carfilzomib) for Injection” NCT02335983 ↗ “Kyprolis® (carfilzomib) for Injection” NCT00511238 ↗ |
| Known as | NSC-758252 | ChEMBL registry synonym — accepted as the source's own label CHEMBL451887 ↗ |
| Known as | PR-171 | “Carfilzomib (formerly PR-171) is a tetrapeptide epoxyketone-based irreversible inhibitor of the 20S proteasome.” NCT03140943 ↗ |
| Action | Inhibit | “Carfilzomib is a proteasome inhibitor” NCT00150462 ↗ |
| Modality | Other / unclassified | “Carfilzomib is a type of drug called a proteasome inhibitor.” NCT02294357 ↗ |
| Route | Intravenous | “Administered as an IV bolus dose” NCT00150462 ↗ |