A Phase 3 interventional study of Elranatamab and Daratumumab in Multiple Myeloma, sponsored by Pfizer. Recruiting at 160 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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 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 rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:
Exclusion Criteria:
Drug: Elranatamab · Drug: Daratumumab · Drug: Lenalidomide
Drug: Elranatamab · Drug: Daratumumab · Drug: Lenalidomide
Drug: Elranatamab · Drug: Daratumumab · Drug: Lenalidomide
Drug: Daratumumab · Drug: Lenalidomide · Drug: Dexamethasone · Drug: Bortezomib
Drug: Elranatamab · Drug: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Randomized
Randomized
Part 1 Dose Limiting Toxicity
Time frame: 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
Part 2: Progression free survival per IMWG
Time frame: From randomization up to 97 months.
Part 2: Minimal Residual Disease negative CR rate
Time frame: At 12 months after randomization
Overall Survival
Time frame: From date of randomization up to 97 months
Overall minimal residual disease negative CR rate
Time frame: From date of randomization up to 97 months
Sustained MRD negative CR rate (Part 2)
Time frame: From date of randomization up to 97 months
Duration of minimal residual disease negative CR (Part 2)
Time frame: From date of minimal residual disease negative CR status up to 97 months
PFS by investigator
Time frame: From date of randomization up to 97 months
PFS2 by investigator (Part 2)
Time frame: From the date of randomization up to 97 months
Objective Response Rate
Time frame: From the date of randomization up to 97 months
Complete Response Rate
Time frame: From the date of randomization up to 97 months
Time to Response
Time frame: From the date of randomization to date of confirmed objective response up to 97 months
Duration of Response
Time frame: From the date of confirmed objective response up to 97 months
Duration of Complete Response
Time frame: From the date of confirmed complete response up to 97 months
Frequency of treatment-emergent adverse events
Time frame: From the date of first dose of study intervention up to 97 months
Frequency of abnormal laboratory results
Time frame: From the date of first dose of study intervention up to 97 months
Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations
Predose and post dose concentrations of elranatamab
Time frame: From date of first dose of study intervention up to 97 months
Incidence of Anti-Drug Antibody against elranatamab
Immunogenicity of elranatamab
Time frame: From date of first dose of study intervention up to 97 months
Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)
Predose concentrations of daratumumab and lenalidomide
Time frame: From date of first dose of study intervention up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the symptom scales/items represent a greater presence of symptoms.
Time frame: From date the informed consent is signed up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma 20 (Part 2)
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Time frame: From date the informed consent is signed up to 97 months
Showing the first 100 of 160 sites across 24 countries.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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