Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Official Title

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

Keywords

Multiple Myeloma, Elranatamab, PF-06863135, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Daratumumab, Pomalidomide, Relapsed multiple myeloma, Refractory multiple myeloma, MagnetisMM-5, Plasma Cell Neoplasms, Dexamethasone

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 and a proteasome inhibitor.
  • 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.

You CAN'T join if...

  • 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.
  • Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
  • 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.

Locations

  • UCSF in progress, not accepting new patients
    Fresno California 93701 United States
  • Community Regional Medical Center in progress, not accepting new patients
    Fresno California 93721 United States
  • Clovis Community Medical Center in progress, not accepting new patients
    Clovis California 93611 United States
  • Community Cancer Institute in progress, not accepting new patients
    Clovis California 93611 United States
  • Christus St. Vincent Regional Cancer Center accepting new patients
    Santa Fe New Mexico 87505 United States
  • Christus St. Vincent Regional Medical Center accepting new patients
    Santa Fe New Mexico 87505 United States
  • Santa Fe Imaging accepting new patients
    Santa Fe New Mexico 87505 United States
  • X-Ray Associates of Santa Fe - XRANM accepting new patients
    Santa Fe New Mexico 87505 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05020236
Phase
Phase 3 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 762 study participants
Last Updated