Elranatamab
- Generic Name
- Elranatamab
- Brand Names
- Elrexfio
- Drug Type
- Biotech
- CAS Number
- 2408850-14-4
- Unique Ingredient Identifier
- L0HR9A577V
- Background
Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. On August 14, 2023, the FDA granted accelerated approval to elranatamab for the treatment of multiple myeloma.
- Indication
Elranatamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
- Associated Conditions
- Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
- First Posted Date
- 2023-09-28
- Last Posted Date
- 2025-04-15
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 80
- Registration Number
- NCT06057402
- Locations
- 🇨🇦
Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦McGill University Health Centre, Montréal, Quebec, Canada
Self-administration of Subcutaneous Elranatamab in the Patients' Homes.
- First Posted Date
- 2023-08-29
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- Thomas Lund
- Target Recruit Count
- 20
- Registration Number
- NCT06015542
- Locations
- 🇩🇰
Odense University Hospital, Odense, Denmark
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma
- First Posted Date
- 2023-07-06
- Last Posted Date
- 2024-10-29
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 514
- Registration Number
- NCT05932290
- Locations
- 🇺🇸
Pfizer, New York, New York, United States
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2023-07-03
- Last Posted Date
- 2025-03-28
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 120
- Registration Number
- NCT05927571
- Locations
- 🇦🇺
Calvary Mater Newcastle, Waratah, New South Wales, Australia
🇦🇺Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
🇦🇺The Alfred Hospital, Prahan, Victoria, Australia
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-01-09
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 90
- Registration Number
- NCT05675449
- Locations
- 🇺🇸
Clinical Research Advisors (Encino Satellite Location), Encino, California, United States
🇺🇸Clinical Research Advisors (Korea Town Satellite Location), Los Angeles, California, United States
🇺🇸Clinical Research Advisors (West Hollywood Satellite Location), Los Angeles, California, United States
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-11-21
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 1116
- Registration Number
- NCT05623020
- Locations
- 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳Chang Gung Medical Foundation-Linkou Branch, Taoyuan, Taiwan
🇦🇺Pindara Private Hospital, Benowa, Queensland, Australia
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
- First Posted Date
- 2022-10-04
- Last Posted Date
- 2024-05-21
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 508
- Registration Number
- NCT05565391
- Locations
- 🇺🇸
Pfizer, New York, New York, United States
Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- First Posted Date
- 2022-07-18
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Pfizer
- Registration Number
- NCT05462639
- Locations
- 🇺🇸
Baptist Hospital of Miami, Miami, Florida, United States
🇺🇸Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
🇺🇸UCLA Hematology/Oncology - Westwood (Building 200 Suite 120), Los Angeles, California, United States
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
- First Posted Date
- 2022-04-07
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 760
- Registration Number
- NCT05317416
- Locations
- 🇫🇷
Hôpital Saint Antoine, Paris Cedex 12, France
🇫🇷Hopital Lyon Sud, Pierre Benite, France
🇺🇸Banner Gateway Medical Center, Gilbert, Arizona, United States
Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)
- Conditions
- Multiple Myeloma
- First Posted Date
- 2022-02-14
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Pfizer
- Registration Number
- NCT05238311
Drug Development Updates
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