Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 4 milestones | |||||
| Filed | EU (EMA) | Empliciti | plasma cell myeloma | 2018-09-18 | “Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd)” bms.com ↗ “In July, the European Medicines Agency (EMA) validated for review the Marketing Authorization Application for elotuzumab” bms.com ↗ |
| Filed | US (FDA) | Empliciti | plasma cell myeloma | 2018-08-23 | “Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd)” bms.com ↗ “In August, the FDA accepted for priority review the Biologics License Application for elotuzumab” bms.com ↗ |
| Clinical hold | US (FDA) | — | plasma cell myeloma | 2017-09-06 | “on partial clinical hold: CheckMate-602: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and...” bms.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 2015-10-30 | “The FDA accepted a Biologics License Application (BLA) for elotuzumab, an investigational treatment in patients with relapsed/refractory multiple myeloma, for priority review.” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | EMPLICITI | — | 2017-05-11 – 2022-03-22 | fda.gov ↗ |
| Approved | EU (EMA) | Empliciti | — | 2016-05-11 | europa.eu ↗ |
| Approved | US (FDA) | EMPLICITI | — | 2015-11-30 | fda.gov ↗ |
Trials 57
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05560399 | Feb 2023 → Nov 2026 expected | plasma cell myeloma | Icahn School of Medicine at Mount Sinai | Active not recruiting | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT05981209 | Dec 2023 → Dec 2026 expected | plasma cell myeloma | Abdullah Khan | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04614636 | Oct 2020 → Jul 2023 | acute myeloid leukemia, plasma cell myeloma | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT03023527 | Jan 2017 → Jan 2018 | plasma cell myeloma | PETHEMA Foundation | Terminated | No outcome recorded |
| Phase 1 | NCT02655458 | Jan 2016 → Jul 2017 | plasma cell myeloma | Hearn Jay Cho | Completed | No outcome recorded |
| Phase 1 | NCT02252263 | Dec 2014 → Oct 2017 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01393964 | Jan 2012 → Mar 2014 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01241292 | Jan 2011 → Feb 2014 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00726869 | May 2008 → Mar 2012 | plasma cell myeloma | Abbott | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00425347 | Dec 2006 → Aug 2008 | plasma cell myeloma | Facet Biotech | Completed | No outcome recorded |
| Phase 1/25 trials · 1 missed | ||||||
| Phase 1/2 | NCT06785415 | Mar 2025 → Apr 2031 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06518551 | Nov 2024 → Dec 2029 expected | plasma cell myeloma | Omar Nadeem, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05002816 | Feb 2022 → Jan 2026 overdue | plasma cell myeloma | Yale University | Active not recruiting | 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 | NCT01668719 | Nov 2012 → Feb 2020 | plasma cell myeloma | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 230 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT05170789 | Apr 2022 | plasma cell myeloma | Tulane University School of Medicine | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04835129 | Jan 2022 → Apr 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04918147 | Oct 2021 → Jan 2024 | immunoglobulin G4-related sclerosing disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT04584307 | Apr 2021 → Dec 2023 | plasma cell myeloma | Natalie Callendar | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04517851 | Feb 2021 → Dec 2027 expected | myelofibrosis, primary myelofibrosis | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03713294 | Jan 2019 → Feb 2024 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03227432 | Dec 2018 → Dec 2021 | plasma cell myeloma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03393273 | Feb 2018 → Jan 2019 | plasma cell myeloma | Assistance Publique - Hôpitaux de Paris | Withdrawn | No outcome recorded |
| Phase 2 | NCT03361306 | Jan 2018 → Jun 2021 | plasma cell myeloma | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03030261 | Nov 2017 → Sep 2022 overdue | plasma cell myeloma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03168100 | Oct 2017 → Jan 2019 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03252600 | Aug 2017 → Dec 2023 | AL amyloidosis | Barbara Ann Karmanos Cancer Institute | Unknown | No outcome recorded |
| 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 | NCT03000634 | Apr 2017 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03104270 | Mar 2017 → Oct 2019 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02843074 | Sep 2016 → Jul 2021 | plasma cell myeloma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02719613 | Jul 2016 → Feb 2026 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02718833 | Jun 2016 → Dec 2026 expected | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02654132 | Mar 2016 → Jan 2018 | plasma cell myeloma | Bristol-Myers Squibb | Completed | Met primary |
| Phase 2 | NCT02612779 | Feb 2016 → Jul 2019 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02375555 | May 2015 → Dec 2021 | plasma cell myeloma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02420860 | Apr 2015 → Apr 2027 expected | disease related to hematopoietic stem cell transplant, plasma cell myeloma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02272803 | Feb 2015 → Feb 2017 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02279394 | Dec 2014 → Dec 2018 | smoldering plasma cell myeloma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02159365 | Mar 2014 → Jun 2016 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01632150 | May 2012 → Oct 2013 | refractory plasma cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01441973 | Dec 2011 → May 2014 | smoldering plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01478048 | Nov 2011 → May 2014 | plasma cell myeloma | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT00742560 | Aug 2008 → Oct 2016 | hematopoietic and lymphoid cell neoplasm | AbbVie | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT06158841 | May 2024 → Dec 2027 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT03651128 | Apr 2019 → Apr 2026 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT03948035 | Aug 2018 → Aug 2029 expected | plasma cell myeloma | Wuerzburg University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02726581 | Aug 2016 → Mar 2022 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT02495922 | Jun 2015 → Jun 2021 | plasma cell myeloma | University of Heidelberg Medical Center | Completed | Missed primary |
| Phase 3 | NCT01891643 | Sep 2013 → Jun 2020 | indolent plasma cell myeloma | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01335399 | Aug 2011 → Oct 2019 | plasma cell myeloma | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 3 | NCT01239797 | Jun 2011 → Sep 2014 | plasma cell myeloma | Bristol-Myers Squibb | Completed | Met primary |
| Phase not stated4 trials | ||||||
| — | NCT02856438 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT02368301 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT02541643 | — | plasma cell myeloma | Sundar Jagannath | No longer available | No outcome recorded |
| — | NCT03126617 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 1/2 | NCT04150965 Comparator | Jul 2020 → Aug 2024 | plasma cell myeloma, refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Terminated | 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 2 | NCT03003728 Background | Nov 2019 → Jul 2020 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 2 | NCT03411031 Comparator | Oct 2018 → Feb 2021 | plasma cell myeloma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01729091 Background | Jun 2013 → Jun 2024 | plasma cell leukemia, plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT07555938 Comparator | Jun 2026 → Oct 2028 expected | plasma cell myeloma | Hoffmann-La Roche | 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 | NCT06208150 Comparator | Jan 2024 → Apr 2026 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05730036 Comparator | Sep 2023 → Apr 2033 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | 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 | NCT05028348 Comparator | Apr 2022 → Mar 2026 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2023-12-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs bms.com ↗
New results from the Phase 1 CC-92480-MM-002 study of oral CELMoD agent mezigdomide, including first results for cohorts evaluating mezigdomide and dexamethasone with monoclonal antibodies (anti-CD38 mAbs) daratumumab and elotuzumab |
| 2020-03-09 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reports Primary Results of ELOQUENT-1 Study Evaluating Empliciti (elotuzumab) Plus Revlimid (lenalidomide) and Dexamethasone in Patients with Newly Diagnosed, Untreated Multiple Myeloma bms.com ↗
At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. |
| 2019-08-27 | Bristol-Myers Squibb | Regulatory European Commission Approves Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma bms.com ↗
We are proud that the European Commission has again recognized the role of Empliciti in helping European patients with multiple myeloma by approving a second Empliciti- based regimen in the relapsed and refractory setting. |
| 2019-07-26 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone for Treatment of Patients with Relapsed and Refractory Multiple Myeloma bms.com ↗
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. |
| 2019-06-14 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Presents Updated Efficacy Data from Phase 2 Trial of Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) bms.com ↗
Treatment with EPd was associated with a 46% reduction in risk of death [Hazard Ratio (HR) 0.54; 95% Confidence Interval (CI): 0.30 to 0.96] versus treatment with Pd alone. |
| 2018-11-29 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Highlight New Data from Broad Oncology Portfolio at the 60th American Society of Hematology Annual Meeting bms.com ↗
First disclosure of results from a Phase 2 trial supports safety and efficacy of Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone in relapsed/refractory (R/R) multiple myeloma |
| 2018-11-06 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma bms.com ↗ |
| 2018-09-18 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma bms.com ↗
Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. |
| 2018-08-23 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma bms.com ↗
The FDA granted the application priority review with an action date of December 27, 2018. |
| 2018-06-17 | Bristol-Myers Squibb | Results Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone Reduces the Risk of Disease Progression by 46% Versus Pomalidomide/Dexamethasone Alone in Patients with Relapsed or Refractory Multiple Myeloma bms.com ↗ |
| 2017-12-05 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Lifts Partial Clinical Holds on Two Opdivo-based Combination Studies in Multiple Myeloma bms.com ↗ |
| 2017-09-06 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Provides an Update on Three Opdivo-based Combination Clinical Studies in Multiple Myeloma bms.com ↗
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma. |
| 2017-06-24 | Bristol-Myers Squibb | Results Four-Year Follow-up with Empliciti (elotuzumab) Plus Lenalidomide/Dexamethasone (ELd) in Patients with Advanced Multiple Myeloma Shows Long-term Efficacy in ELOQUENT-2 Trial bms.com ↗
ELd therapy maintained a reduction in the risk of disease progression or death of 29% (HR 0.71; 95% CI: 0.59 to 0.86). |
| 2016-05-11 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AbbVie Announce European Commission Approval of Empliciti™ (elotuzumab) for the Treatment of Multiple Myeloma in Adult Patients Who Have Received at Least One Prior Therapy bms.com ↗
Empliciti is now the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU). |
| 2016-01-29 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AbbVie Receive Positive CHMP Opinion for Investigational Antibody, Empliciti (elotuzumab), for the Treatment of Multiple Myeloma in Patients Who Have Received at Least One Prior Therapy bms.com ↗ |
| 2015-11-30 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AbbVie Receive FDA Approval of Empliciti™ (elotuzumab) for the Treatment of Patients with Multiple Myeloma Who Have Received One to Three Prior Therapies bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid ® (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies. |
| 2015-09-01 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review the Biologics License Application for Empliciti (elotuzumab) for the Treatment of Multiple Myeloma in Patients Who Have Received One or More Prior Therapies bms.com ↗
This acceptance for review marks the first in the U.S. for a SLAMF7-directed immunostimulatory antibody |
| 2015-07-27 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates and Grants Accelerated Assessment of Marketing Authorization Application for Empliciti (elotuzumab) For the Treatment of Multiple Myeloma in Patients Who Have Received One or More Prior Therapies bms.com ↗
The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). |
| 2015-06-11 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Demonstrates Commitment to Hematology and Advancing Research and Development Across Multiple Blood Cancers Through Immuno-Oncology Leadership at the 20th Congress of the European Hematology Association bms.com ↗
Results from two trials (ELOQUENT-2 & 009) in which elotuzumab’s novel mechanism of action demonstrated a significant and sustained reduction in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma to be presented |
| 2015-06-02 | Bristol-Myers Squibb | Results Adding Investigational Agent Elotuzumab to Standard Treatment for Multiple Myeloma Significantly Reduced the Risk of Disease Progression, According to New Phase III Data from ELOQUENT-2 Trial Published in New England Journal of Medicine bms.com ↗
The study met its co-primary endpoints demonstrating superior progression-free survival (PFS) and overall response rate (ORR). |
| 2014-05-19 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma bms.com ↗ |
| 2013-07-26 | AbbVie | Results AbbVie Reports Second-Quarter 2013 Financial Results abbvie.com ↗
Results demonstrated median progression-free survival of 33 months and an objective response rate of 92 percent among patients treated with the investigational monoclonal antibody elotuzumab (10 mg/kg) in combination with lenalidomide and low-dose dexamethasone. |
| 2013-06-15 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and AbbVie Announce Progression-Free Survival Data from Phase 2 Open-Label Study of Investigational Agent Elotuzumab in Combination with Lenalidimide and Dexamethasone in Previously-Treated Multiple Myeloma bms.com ↗
Median progression-free survival (PFS) of 33 months reached after longer-term follow up in patients treated with elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone |
| 2012-12-09 | Bristol-Myers Squibb | Results Elotuzumab Progression-Free Survival Data from Phase 2 Study of Patients with Previously-Treated Multiple Myeloma Presented at 54th American Society of Hematology (ASH) Annual Meeting bms.com ↗
In the 10 mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the objective response rate (ORR) was 92%. |
| 2010-12-07 | Bristol-Myers Squibb | Results Encouraging Phase 2 Interim Data for Elotuzumab in Relapsed Multiple Myeloma Presented at 52nd American Society of Hematology Annual Meeting bms.com ↗
Of 31 previously-treated patients who received elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone, 28 (90%) achieved an objective response. |
| 2009-12-07 | Bristol-Myers Squibb | Results Facet Biotech and Bristol-Myers Squibb Report Promising Phase I/II Interim Data for Elotuzumab in Patients with Relapsed Multiple Myeloma bms.com ↗
The interim results given as an oral presentation today showed that of the 28 treated patients in the trial, 23 (82 percent) had an objective response (OR) by International Myeloma Working Group (IMWG) criteria. |
All press releases naming this drug 29 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 72 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elotuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02279394 ↗ |
| Known as | BMS-901608 | “Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma” NCT02541643 ↗8“Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone” NCT01241292 ↗ “Biological:Elotuzumab (BMS-901608; HuLuc63)” NCT02654132 ↗ “Biological: Elotuzumab (BMS-901608)” NCT02272803 ↗ “Elotuzumab is known as BMS-901608.” NCT02655458 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01335399 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01441973 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01393964 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01239797 ↗ |
| Known as | Elo | “This phase II study combined elotuzumab (Elo) with carfilzomib, lenalidomide, and dexamethasone (KRd) for treatment of MM in first relapse with the aim of improving efficacy.” PMID 37127471 ↗ Apr 20232“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 ↗ “Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd)” NCT03651128 ↗ |
| Known as | Empliciti | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743010 ↗ |
| Known as | HuLuc63 | “Biological:Elotuzumab (BMS-901608; HuLuc63)” NCT02654132 ↗6“Elotuzumab (BMS-901608; HuLuc63)” NCT01393964 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01335399 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01441973 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01239797 ↗ “Elotuzumab (HuLuc63)” NCT00726869 ↗ |
| Known as | PDL-063 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743010 ↗ |
| Action | Activate | “works by activating natural killer cells already present in the body” NCT03003728 ↗ |
| Modality | Monoclonal antibody | “Humanized Anti-CS1 Monoclonal IgG1 Antibody” NCT00425347 ↗ |
| Route | Intravenous | “administered intravenously (IV)” NCT00425347 ↗ |
| Target | SLAMF7 | “Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7)” PMID 26035255 ↗ Jun 2015 |