OncoMatch/Clinical Trials/NCT05623020
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
Is NCT05623020 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Elranatamab and Daratumumab for multiple myeloma.
Treatment: Elranatamab · Daratumumab · Lenalidomide · Dexamethasone — 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 combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory drug
received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor
Must have received: proteasome inhibitor
received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor
Cannot have received: BCMA-directed therapy
Previous treatment with a BCMA-directed therapy
Cannot have received: anti-CD38-directed therapy
Exception: within 6 months preceding the first dose of study intervention
anti-CD38-directed therapy within 6 months preceding the first dose of study intervention
Cannot have received: stem cell transplant
Exception: ≤3 months prior to first dose of study intervention or active GVHD
Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD
Cannot have received: systemic corticosteroids
Exception: cumulative dose equivalent to ≥20 mg of dexamethasone during screening
A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening
Cannot have received: systemic treatment for MM
Exception: except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention)
Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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