Status:
RECRUITING
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
Lead Sponsor:
Pfizer
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy inclu...
Eligibility Criteria
Inclusion Criteria:
-
Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
-
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL.
- Urinary M-protein excretion ≥200 mg/24 hours.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
-
Prior anti-multiple myeloma therapy including treatment with lenalidomide.
-
ECOG performance status ≤2.
-
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
-
Not pregnant and willing to use contraception.
Exclusion Criteria:
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- POEMS Syndrome.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous treatment with a BCMA-directed therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
944 Patients enrolled
Trial Details
Trial ID
NCT05020236
Start Date
October 4 2021
End Date
May 31 2027
Last Update
March 27 2026
Active Locations (238)
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1
Clovis Community Medical Center
Clovis, California, United States, 93611
2
Community Cancer Institute
Clovis, California, United States, 93611
3
University of California San Francisco
Fresno, California, United States, 93701
4
Community Regional Medical Center
Fresno, California, United States, 93721