Drugs / Elotuzumab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 |
| Phase 1 | NCT00425347 | Dec 2006 → Aug 2008 | plasma cell myeloma | Facet Biotech | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| 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 | No outcome recorded |
| Phase 230 trials | ||||||
| Phase 2 | NCT05170789 | Apr 2022 | plasma cell myeloma | Tulane University School of Medicine | Withdrawn | No outcome recorded |
| 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 |
| 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 |
| 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 |
| 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 | No outcome recorded |
| Phase 2 | NCT03000634 | Apr 2017 | plasma cell myeloma | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 2 | NCT03104270 | Mar 2017 → Oct 2019 | plasma cell myeloma | Oncotherapeutics | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT00742560 | Aug 2008 → Oct 2016 | hematopoietic and lymphoid cell neoplasm | AbbVie | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01891643 | Sep 2013 → Jun 2020 | indolent plasma cell myeloma | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 3 | NCT01335399 | Aug 2011 → Oct 2019 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01239797 | Jun 2011 → Sep 2014 | plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT02856438 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT02541643 | — | plasma cell myeloma | Sundar Jagannath | No longer available | No outcome recorded |
| — | NCT02368301 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
| — | NCT03126617 | — | plasma cell myeloma | Bristol-Myers Squibb | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 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 23 trials | ||||||
| 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 37 trials | ||||||
| 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 |
| 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 | 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 |
| Phase 3 | NCT05028348 Comparator | Apr 2022 → Mar 2026 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-12-05 | Bristol-Myers Squibb | New Longer-Term Data for Empliciti (elotuzumab) Showed a Continued Progression-Free Survival Benefit in Patients with Relapsed or Refractory Multiple Myeloma bms.com ↗ |
| 2015-11-30 | Bristol-Myers Squibb | 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 ↗ |
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 NCT04517851 ↗67 |
| 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)” NCT01239797 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01335399 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01393964 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01441973 ↗ |
| 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)” NCT01335399 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01239797 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01441973 ↗ “Elotuzumab (BMS-901608; HuLuc63)” NCT01393964 ↗ “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 |