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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sylvester Comprehensive Cancer Center - Aventura
  Aventura, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
  Coral Gables, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center - Coral Springs
  Coral Springs, Florida, United States Recruiting
• University of Miami Hospital and Clinics - Deerfield Beach
  Deerfield Beach, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center - Hollywood
  Hollywood, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

+187 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.