MedPath

Elotuzumab

Generic Name
Elotuzumab
Brand Names
Empliciti
Drug Type
Biotech
CAS Number
915296-00-3
Unique Ingredient Identifier
1351PE5UGS
Background

Elotuzumab is a humanized IgG1 (Immunoglobulin G) monoclonal antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Elotuzumab targets SLAMF7, also known as Signaling Lymphocytic Activation Molecule Family member 7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. Elotuzumab was approved on November 30, 2015 by the U.S. Food and Drug Administration. Elotuzumab is marketed under the brand Empliciti™ by Bristol-Myers Squibb.

Indication

Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Associated Conditions
Refractory Multiple Myeloma

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

Conditions
Multiple Myeloma
First Posted Date
2015-09-04
Last Posted Date
2015-09-04
Lead Sponsor
Sundar Jagannath
Registration Number
NCT02541643
Locations
🇺🇸

Icahn School.of Medicine at Mount Sinai, New York, New York, United States

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

Phase 3
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2015-07-13
Last Posted Date
2021-09-10
Lead Sponsor
University of Heidelberg Medical Center
Target Recruit Count
564
Registration Number
NCT02495922
Locations
🇩🇪

Schwarzwald-Baar Klinikum, Klinik für Innere Medizin II, Villingen-Schwenningen, Germany

🇩🇪

Rems-Murr-Klinikum gGmbH Winnenden, Winnenden, Germany

🇩🇪

Studienzentrum Aschaffenburg, Aschaffenburg, Germany

and more 64 locations

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

Phase 2
Active, not recruiting
Conditions
Hematopoietic Cell Transplantation Recipient
Plasma Cell Myeloma
Interventions
Other: Questionnaire Administration
First Posted Date
2015-04-20
Last Posted Date
2025-05-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
113
Registration Number
NCT02420860
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

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

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2015-03-02
Last Posted Date
2024-09-30
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
40
Registration Number
NCT02375555
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

and more 4 locations

Expanded Access Treatment Protocol CA204-143

Conditions
Multiple Myeloma
First Posted Date
2015-02-23
Last Posted Date
2023-11-30
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT02368301

Selinexor and Backbone Treatments of Multiple Myeloma Patients

First Posted Date
2015-01-21
Last Posted Date
2024-05-07
Lead Sponsor
Karyopharm Therapeutics Inc
Target Recruit Count
300
Registration Number
NCT02343042
Locations
🇺🇸

Sarah Cannon-Colorado Blood Cancer Institute, Denver, Colorado, United States

🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

🇺🇸

Swedish Cancer Institute, Seattle, Washington, United States

and more 21 locations

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

Phase 2
Completed
Conditions
Smoldering Myeloma
Smoldering Multiple Myeloma
Interventions
First Posted Date
2014-10-31
Last Posted Date
2023-06-09
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
51
Registration Number
NCT02279394
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

University of Maryland, Baltimore, Maryland, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 6 locations

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

Phase 1
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2014-09-30
Last Posted Date
2017-11-01
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
44
Registration Number
NCT02252263
Locations
🇪🇸

Local Institution, Pamplona, Navarra, Spain

🇺🇸

The Ohio State University, Columbus, Ohio, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 4 locations

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

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2014-06-09
Last Posted Date
2019-07-16
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
84
Registration Number
NCT02159365
Locations
🇺🇸

Baptist Health Medical Group Oncology, Miami, Florida, United States

🇺🇸

Investigative Clinical Research Of Indiana, Llc, Indianapolis, Indiana, United States

🇺🇸

Comprehensive Blood And Cancer Center, Bakersfield, California, United States

and more 26 locations

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

Phase 2
Completed
Conditions
Plasma Cell Leukemia
Plasma Cell Myeloma
Interventions
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy
First Posted Date
2012-11-20
Last Posted Date
2025-05-09
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
72
Registration Number
NCT01729091
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

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