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Empliciti

(Elotuzumab)

Phase 3Monoclonal antibody

Bristol-Myers Squibb

Elotuzumab is used to treat multiple myeloma, a type of blood cancer. It works by helping the immune system recognize and destroy cancer cells.[1] Empliciti is currently being investigated across 5 indications[3], with its most advanced program in Phase 3.[1]

Empliciti is one of 125 biologic programs targeting Amyloidosis. It is currently in Phase 3.

5

Indications

63

Total Trials

21

Active Trials

124

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AmyloidosisActive, not recruiting

MyelofibrosisActive, not recruiting

Plasma Cell LeukemiaActive, not recruiting

Multiple MyelomaRecruiting

Recurrent Multiple MyelomaRecruiting

AmyloidosisPhase 2

Active, not recruiting

MyelofibrosisPhase 2

Active, not recruiting

Plasma Cell LeukemiaPhase 2

Active, not recruiting

Multiple MyelomaPhase 3

Recruiting

Recurrent Multiple MyelomaPreclinical

Recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Empliciti

Bristol-Myers Squibb

Ninlaro

Prolia

Eliquis

Bristol-Myers Squibb

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Nolvadex

Adriamycin

GGynecologic Oncology Group

Oncovin

EEastern Cooperative Oncology Group

Intron a

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Multiple Myeloma

NCT03989414

Phase 1/2Recruiting

Multiple Myeloma

NCT05002816

Phase 1Active, not recruiting

Multiple Myeloma

NCT05560399

Phase 1Recruiting

Relapsed or Refractory

NCT05981209

Q1 2027

Phase 2Recruiting

Multiple Myeloma

NCT04835129

Q2 2027

Phase 1/2Recruiting

Multiple Myeloma

NCT02343042

Clinical

Trials by Indication[1]

Multiple Myeloma44 trials

Combination Study for High Risk Multiple Myeloma Patients

Terminated·OOncotherapeutics·Phase 2·NCT03104270·13 enrolled

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma

Active, not recruiting·SSWOG Cancer Research Network·Phase 1/2·NCT01668719·142 enrolled

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04835129·53 enrolled

Show 41 more trials

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

Active, not recruiting·EEuropean Myeloma Network B.V.·Phase 3·NCT05028348·117 enrolled

Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT03713294·37 enrolled

Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01632150·51 enrolled

LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma

Completed·WWake Forest University Health Sciences·Phase 2·NCT03361306·15 enrolled

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02159365·84 enrolled

2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Withdrawn·UUniversity of Arkansas·Phase 2·NCT03168100

Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma

Recruiting·YYale University·Phase 1/2·NCT05002816·24 enrolled

Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma

Completed·HHearn Jay Cho·Phase 1·NCT02655458·15 enrolled

Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT02843074·53 enrolled

Selinexor and Backbone Treatments of Multiple Myeloma Patients

Recruiting·KKaryopharm Therapeutics Inc·Phase 1/2·NCT02343042·300 enrolled

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03989414·424 enrolled

Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01729091·72 enrolled

Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT03030261·25 enrolled

Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines

Completed·RRaija Silvennoinen·Phase 2·NCT03155100·15 enrolled

Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01393964·35 enrolled

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01239797·646 enrolled

A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.

Terminated·AAbbott·Phase 1·NCT00726869·28 enrolled

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01335399·748 enrolled

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01478048·185 enrolled

A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02252263·44 enrolled

Elotuzumab in Patients With Multiple Myeloma Before and After Peripheral Stem Cell Autologous Graft

Withdrawn·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03393273

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01891643·23 enrolled

Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma

No longer available·SSundar Jagannath··NCT02541643

An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma

Withdrawn·—·Phase 2·NCT03227432

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02726581·170 enrolled

A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Active, not recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT05560399·7 enrolled

A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT02718833·52 enrolled

An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02654132·117 enrolled

E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Completed·—·Phase 2·NCT02279394·51 enrolled

A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02612779·74 enrolled

Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02420860·113 enrolled

Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03126617

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06232707

Nivolumab Role in the Treatment of Patients With Refractory or Relapse Multiple Myeloma

Terminated·PPETHEMA Foundation·Phase 1·NCT03023527·6 enrolled

Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma

Completed·UUniversity of Chicago·Phase 2·NCT02969837·46 enrolled

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma

Completed· AbbVie logo

AbbVie·Phase 2·NCT00742560·101 enrolled

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT05730036·410 enrolled

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06152575·492 enrolled

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06158841·380 enrolled

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy

Recruiting· Roche logo

Roche·Phase 3·NCT07555938·380 enrolled

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03651128·386 enrolled

Newly Diagnosed3 trials

Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM

Completed·—·Phase 2·NCT02375555·40 enrolled

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02272803·82 enrolled

A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma

Completed·UUniversity of Heidelberg Medical Center·Phase 3·NCT02495922·564 enrolled

Relapsed or Refractory2 trials

Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies

Recruiting·AAbdullah Khan·Phase 1·NCT05981209·27 enrolled

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06208150·795 enrolled

Treatment2 trials

Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02719613·67 enrolled

Early Patient Access Treatment Use Protocol CA204-220

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02856438

Dexamethasone2 trials

Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd in MM

Active, not recruiting·WWuerzburg University Hospital·Phase 3·NCT03948035·576 enrolled

Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

Recruiting·—·Phase 1/2·NCT06518551·49 enrolled

10 more indications

High Risk1 trial

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01441973·41 enrolled

Stem Cell Transplant1 trial

2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT)

Withdrawn·UUniversity of Arkansas·Phase 2·NCT03003728

Pomalidomide1 trial

Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant

Withdrawn·NNatalie Callendar·Phase 2·NCT04584307

Advanced Hematologic Malignancies1 trial

FT538 in Subjects With Advanced Hematologic Malignancies

Terminated·FFate Therapeutics·Phase 1·NCT04614636·42 enrolled

Myelofibrosis1 trial

Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04517851·15 enrolled

Maintenance Therapy1 trial

2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy

Withdrawn·UUniversity of Arkansas·Phase 2·NCT03000634

Immunoglobulin G4-related Disease1 trial

Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04918147·8 enrolled

Lenalidomide1 trial

Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT03411031·18 enrolled

Amyloidosis1 trial

Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis

Unknown status·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT03252600·53 enrolled

Recurrent Multiple Myeloma1 trial

Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma

Recruiting·MMayo Clinic·Preclinical·NCT06785415·37 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 30, 2015

EMPLICITI

BLA BLA761035

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Elotuzumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Elotuzumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Elotuzumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761035). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: SLAM Family Member 7 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

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