A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Recruiting
Phase 3
Interventional Study
Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,116 (estimated)
- Sponsor
- Pfizer · Industry
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About This Trial
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, Bortezomib, Lenalidomide and Dexamet…
Trial Locations
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Eligibility Criteria
Inclusion 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 (Part 1) and ≥1 g/dL (Part 2);
* Urinary M-protein excretion ≥200 mg/2…
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