NCT05623020
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
PHASE3Ages 18+InterventionalTreatmentPfizer
~1,116 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:ElranatamabDaratumumabLenalidomideDexamethasoneBortezomib
At a glance
Recruiting sites
111 of 127 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 Dose Limiting Toxicity
Measured over From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
+2 more outcomes measured
Conditions
Where it's being run
127 sites across 85 statesNew York5
Italy5
Spain5
Victoria4
Japan4
Seoul-teukbyeolsi [seoul]4
Taiwan4
New Jersey3
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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/24 hours;
Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \<65 years with comorbidities impacting the possibility of transplant.
Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:
Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
ECOG performance status ≤2.
Not pregnant and willing to use contraception
For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Exclusion
Smoldering Multiple Myeloma.
Monoclonal gammopathy of undetermined significance.
Waldenströms Macroglobulinemia
Plasma cell leukemia.
Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
For participants with NDMM: 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). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
What this trial measures
- Part 1 Dose Limiting ToxicityFrom the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
- Part 2: Progression free survival per IMWGFrom randomization up to 97 months.
- Part 2: Minimal Residual Disease negative CR rateAt 12 months after randomization