Study on Elranatamab for Relapsed/Refractory Multiple Myeloma

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06138275

Provider View

This clinical trial is testing whether the drug elranatamab can help slow down or stop the progression of multiple myeloma in patients whose disease has returned or not responded to previous treatments, including idecabtagene vicleucel.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug elranatamab can help control multiple myeloma that has come back or not responded to other treatments. Participants will receive elranatamab for up to 6 months and will be monitored to see if their disease worsens or if they need to start a new treatment. Elranatamab is a type of antibody that helps the immune system target and kill myeloma cells. This drug is not yet approved by the FDA for treating any disease. About 32 people are expected to participate in this study.

Description

This study is open to patients with relapsed and refractory multiple myeloma who have already tried at least four different treatments, including idecabtagene vicleucel. Participants will receive the study drug, elranatamab, and attend study visits for up to 6 months. The study will continue until the disease worsens or another treatment is needed. Elranatamab works by helping the immune system's T-cells attack myeloma cells. The study aims to see if this approach can slow down or stop the progression of multiple myeloma. Participants will be closely monitored throughout the study to ensure their safety and to assess the drug's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate in the study.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must be 18 years or older.
  • Must agree to use effective birth control during the study and for a specified time after.
  • Must have a prior diagnosis of multiple myeloma with measurable disease.
  • Must have previously received idecabtagene vicleucel and at least four other treatments.
  • Must have adequate heart function and organ health as determined by specific medical tests.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have certain other types of blood disorders or conditions like smoldering myeloma or amyloidosis.
  • Cannot have had a stem cell transplant within 12 weeks before joining the study.
  • Cannot have active infections like hepatitis B, hepatitis C, or HIV.
  • Cannot have significant heart problems or recent heart events.
  • Cannot have other active cancers within the last 3 years, except for certain skin cancers.
  • Cannot have severe nerve damage or a history of certain nerve disorders.
  • Cannot have been treated with an anti-BCMA bispecific antibody before.
  • Cannot be pregnant or breastfeeding.
  • Cannot have allergies to the study drug or its ingredients.
  • Cannot be participating in another clinical trial for the same condition.
  • Cannot have received a live vaccine within 4 weeks before starting the study.
  • Must have recovered from any side effects of previous cancer treatments before starting the study.
  • Cannot have had major surgery within 14 days before joining the study.
  • Cannot have taken another investigational drug within 30 days before starting the study.

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