A Study to Learn About Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant or Who Will Not Receive a Transplant as Initial Therapy

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in

Trial Details

NCT ID
NCT05623020
Phase
PHASE3
Sponsor
Pfizer
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Elranatamab
  • Daratumumab
  • Lenalidomide
  • Dexamethasone
Locations (sample)
  • Benowa, Queensland, Australia|-28.0077,153.38583
  • Fitzroy, Victoria, Australia|-37.79839,144.97833
  • Melbourne, Victoria, Australia|-37.814,144.96332
  • Fredericton, New Brunswick, Canada|45.94541,-66.66558
  • Halifax, Nova Scotia, Canada|44.64269,-63.57688

Key Eligibility Criteria

  • Diagnosis of multiple myeloma (MM) 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;

For full eligibility, visit ClinicalTrials.gov.

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