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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 60 (238 locations)

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

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments | DecenTrialz