Drugs / Elotuzumab
last change Aug 2026 re-read 9 days ago

Elotuzumab

also known as BMS-901608 · HuLuc63 · Elo · Empliciti · PDL-063

Monoclonal antibody targets SLAMF7 via activation

Developed for
plasma cell myeloma · smoldering plasma cell myeloma · AL amyloidosis · hematopoietic and lymphoid cell neoplasm · immunoglobulin G4-related sclerosing disease · indolent plasma cell myeloma · myelofibrosis · primary myelofibrosis
+1 more · refractory plasma cell neoplasm
Investigated by
Bristol-Myers Squibb · AbbVie · Celgene Corporation · Multiple Myeloma Research Consortium · Dana-Farber Cancer Institute · National Cancer Institute (NCI)
+42 more · Abbott · Amgen · Karyopharm Therapeutics Inc · M.D. Anderson Cancer Center · Mayo Clinic · University of Arkansas · Abdullah Khan · Adknoma Health Research · Assistance Publique - Hôpitaux de Paris · Atrium Health Levine Cancer Institute · Autoimmunity Centers of Excellence · Barbara Ann Karmanos Cancer Institute · Blood Cancer Research Partnership · ClinAssess · Facet Biotech · Fate Therapeutics · GlaxoSmithKline · Hearn Jay Cho · Hospital District of Helsinki and Uusimaa · Icahn School of Medicine at Mount Sinai · Massachusetts General Hospital · Medical College of Wisconsin · Multiple Myeloma Research Foundation · Natalie Callendar · National Institute of Allergy and Infectious Diseases (NIAID) · Omar Nadeem, MD · Oncotherapeutics · PETHEMA Foundation · Raija Silvennoinen · Rho Federal Systems Division, Inc. · SCRI Development Innovations, LLC · SWOG Cancer Research Network · Study Group of Medical Tumour Therapy (AGMT) · Sundar Jagannath · The Leukemia and Lymphoma Society · Tulane University School of Medicine · University of Chicago · University of Heidelberg Medical Center · Wake Forest University Health Sciences · Washington University School of Medicine · Wuerzburg University Hospital · Yale University

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 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

News releases announcing trial results or a regulatory action · 26

DateIssuerRelease
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.

All press releases naming this drug 29 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 72 sources stand behind the page.

FieldValueCited text
Known as Elotuzumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT02279394 ↗
67

NCT01241292 ↗

NCT06518551 ↗

NCT01239797 ↗

NCT01891643 ↗

NCT02420860 ↗

NCT02368301 ↗

NCT02654132 ↗

NCT03411031 ↗

NCT05730036 ↗

NCT03126617 ↗

Show 57 more sources

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 2023
2

“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 ↗

NCT00425347 ↗

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