Evaluating Elranatamab for Relapsed Multiple Myeloma

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 study aims to evaluate the effectiveness of elranatamab, a bispecific antibody targeting B-cell maturation antigen (BCMA), in patients with relapsed multiple myeloma who have previously undergone treatment. Participants will be randomly assigned to receive either elranatamab or a combination of standard therapies selected by the study doctor. The treatment will involve weekly subcutaneous injections of elranatamab, while the combination therapy will include oral medications and injections. The goal is to compare the outcomes of elranatamab against established treatment regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Have clinical laboratory values within the specified range.
* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
* Not pregnant or breastfeeding and willing to use contraception.

Exclusion Criteria:

* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
* Unable to receive investigator's choice therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.

Where it's running

• Infirmary Cancer Care
  Mobile, Alabama, United States Recruiting
• Beverly Hills Cancer Center
  Beverly Hills, California, United States Recruiting
• Clovis Community Medical Center
  Clovis, California, United States Recruiting
• Community Cancer Institute
  Clovis, California, United States Recruiting
• Clinical Research Advisors (Encino Satellite Location)
  Encino, California, United States Recruiting
• University of California San Francisco
  Fresno, California, United States Recruiting

+220 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.

• Elranatamab given as outpatient in relapsed or refractory multiple myeloma

  This study tests a bispecific antibody called elranatamab, given in an outpatient setting to adults with relapsed or refractory multiple myeloma who have had prior therapies.

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• Elranatamab plus cyclophosphamide for relapsed/refractory multiple myeloma with high-risk features

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• Elranatamab with lenalidomide and dexamethasone for newly diagnosed multiple myeloma.

  This trial will test whether adding elranatamab to lenalidomide and dexamethasone helps people newly diagnosed with multiple myeloma.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06997081

• Mezigdomide plus elranatamab for relapsed or refractory multiple myeloma

  This test tries adding mezigdomide to elranatamab (with dexamethasone) to see if it is safe and can help adults with relapsed or refractory multiple myeloma who have had 1–4 prior treatments (eligibility differs by phase).

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• Personalized dendritic cell–myeloma fusion vaccine combined with elranatamab for relapsed or refractory multiple myeloma

  This will try a personalized dendritic cell–myeloma fusion vaccine given with elranatamab in people with relapsed or refractory multiple myeloma.

  Recruiting at 2 sites Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts and 1 other locations · NCT06799026

• Evaluating elranatamab for treating relapsed or refractory multiple myeloma

  This study is testing a new treatment called elranatamab to see if it can help people with relapsed or refractory multiple myeloma who have already tried other therapies.

  Recruiting Phase 2 University of California, San Diego · La Jolla, California · NCT06711705

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.