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Elranatamab alone or with daratumumab for people with multiple myeloma after prior treatment

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

Phase 3 Interventional Pfizer · NCT05020236

This trial will test whether the BCMA-targeting drug elranatamab alone or together with daratumumab helps people with multiple myeloma who have already been treated with lenalidomide, compared with daratumumab plus pomalidomide and dexamethasone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment944 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionselranatamab, daratumumab
Locations90 sites (Clovis, California and 89 other locations)
Trial IDNCT05020236 on ClinicalTrials.gov

What this trial studies

This is a multi-part Phase 3 trial testing the BCMA-CD3 bispecific antibody elranatamab as a single agent and in combination with the anti-CD38 antibody daratumumab in people with previously treated multiple myeloma. Part 1 explores safety and activity of different elranatamab doses when given with daratumumab. In Part 2 participants are randomized to elranatamab alone, elranatamab plus daratumumab, or daratumumab with pomalidomide and dexamethasone to compare safety and anti-myeloma activity. Later parts will expand evaluation of efficacy and longer-term outcomes in larger patient groups.

Who should consider this trial

Good fit: People with measurable multiple myeloma who have received prior anti-myeloma therapy including lenalidomide, have ECOG performance status 0–2, and meet baseline safety requirements are the intended participants.

Not a fit: Patients with smoldering myeloma, plasma cell leukemia, amyloidosis, POEMS syndrome, recent stem cell transplant or active graft-versus-host disease, active uncontrolled infections (including HBV, HCV, HIV, SARS-CoV-2), or other active malignancies are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could provide a new effective treatment option for people with previously treated multiple myeloma and potentially improve response rates or delay disease progression.

How similar studies have performed: Earlier-phase trials of elranatamab and other BCMA-targeting bispecific antibodies have shown promising response rates in relapsed/refractory multiple myeloma, and daratumumab-containing combinations are an established treatment backbone.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Prior diagnosis of multiple myeloma 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.
  * Urinary M-protein excretion ≥200 mg/24 hours.
  * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Prior anti-multiple myeloma therapy including treatment with lenalidomide.
* ECOG performance status ≤2.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
* Not pregnant and willing to use contraception.

Exclusion Criteria:

* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* POEMS Syndrome.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
* Previous treatment with a BCMA-directed therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Where this trial is running

Clovis, California and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaElranatamabPF-06863135B-Cell Maturation AntigenBCMABispecific antibodyBCMA-CD3 bispecific antibodyDaratumumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.