A Phase 3 interventional study of Elranatamab and Daratumumab in Multiple Myeloma, sponsored by Pfizer. Recruiting at 237 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.
Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.
People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.
Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.
All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 893 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Exclusion Criteria:
Drug: Elranatamab · Drug: Daratumumab
Drug: Elranatamab
Drug: Elranatamab · Drug: Daratumumab
Drug: Daratumumab · Drug: Pomalidomide · Drug: Dexamethasone
Drug: Elranatamab
Drug: Elranatamab · Drug: Daratumumab
subcutaneous
Also known as: PF-06863135
Daratumumab / hyaluronidase, subcutaneous
Also known as: Darzalex Faspro; Darzalex solution for injection
oral
Also known as: Pomalyst, Imnovid
oral
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
Time frame: First 42 days after first elranatamab dose
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Part 3: Frequency of treatment-emergent adverse events
Time frame: First 84 days after first elranatamab dose
Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Overall survival
Time frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Objective response rate per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Duration of response per International Myeloma Working Group criteria
Time frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Time to response per International Myeloma Working Group criteria
Time frame: From date of randomization to date of confirmed objective response, assessed up to 51 months
Complete response rate per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Duration of complete response per International Myeloma Working Group criteria
Time frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Minimal residual disease negativity rate per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Progression free survival on next-line treatment per International Myeloma Working Group criteria
Time frame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Frequency of treatment-emergent adverse events
Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Frequency of abnormal laboratory results
Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Rate of Grade ≥2 cytokine release syndrome
Time frame: First 28 days after first elranatamab dose
Elranatamab pharmacokinetics by pre- and post-dose concentrations
Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab
Daratumumab pharmacokinetics by pre-dose concentrations
Time frame: From date of first dose through up to 14 days after date of last dose of daratumumab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention
Showing the first 100 of 237 sites across 26 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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