Study on Elranatamab for Treating Multiple Myeloma That Has Returned or Not Responded to Treatment

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05014412

Provider View

This clinical trial is testing a new medicine, Elranatamab, to see if it is safe and effective for people with multiple myeloma that has come back or not responded to previous treatments. The study involves gradually increasing doses of the medicine given as an injection under the skin.

Patient Parameters

Program Overview

The study aims to find out if Elranatamab, a new medicine, is safe and can help treat multiple myeloma that has returned or not responded to treatment. Participants will receive injections of Elranatamab at the clinic, starting with lower doses that gradually increase. After the initial doses, participants will receive the medicine once a week, and the frequency of clinic visits may decrease over time. The study will last at least two years.

Description

This study is testing the safety and effectiveness of Elranatamab, a new type of medicine called a bispecific antibody, for people with multiple myeloma that has returned or not responded to treatment. Elranatamab works by helping the body's immune cells target and destroy cancer cells. Participants will receive injections of Elranatamab under the skin at the clinic. The study will start with lower doses that gradually increase to find the safest and most effective dose. After the initial doses, participants will receive the medicine once a week, and the frequency of clinic visits may decrease over time. The study will last at least two years, and researchers will monitor participants for any side effects and how well the medicine works.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma.
  • Have measurable disease based on specific medical tests.
  • Have not responded to at least one type of treatment, including IMiD, PI, and anti-CD38 antibody.
  • Have not responded to the last treatment for multiple myeloma.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Any side effects from previous treatments must have resolved to a mild level.
  • Not pregnant and willing to use contraception during the study.

Exclusion Criteria

  • Have smoldering multiple myeloma or active plasma cell leukemia.
  • Have POEMS syndrome, amyloidosis, or Waldenström's macroglobulinemia.
  • Have cancer that has spread to the brain or spinal cord.
  • Have had a stem cell transplant within the last 12 weeks or have active graft-versus-host disease.
  • Have active infections like hepatitis B, hepatitis C, COVID-19, or HIV.
  • Have had another active cancer within the last three years, except for certain skin cancers or very early-stage cancers.
  • Have previously received treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
  • Have received a live vaccine within four weeks before starting the study.
  • Have taken another investigational drug within 30 days or five half-lives before starting the study.
  • Have known allergies to the study medicine or its ingredients.

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