Study on REGN5458 for Adults with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03761108

Provider View

This clinical trial is testing the safety and best dosage of a new drug, REGN5458, for adults with multiple myeloma that has returned or is difficult to treat. The study also aims to see if REGN5458 can help treat the cancer.

Patient Parameters

Program Overview

The main goal of this study is to find out if the new drug REGN5458 is safe and to determine the best dose for patients with multiple myeloma, a type of blood cancer. Researchers are also looking for signs that REGN5458 can help treat the cancer. They will study the side effects, how the drug works in the body, how much of it is in the blood, and how it might work against cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Confirmed diagnosis of active multiple myeloma.
  • Cancer must be measurable according to specific criteria.
  • For Phase 1, Part 1: Must have tried all available treatments without success, including at least three different therapies, or have disease that is resistant to treatment.
  • For Phase 1, Part 2: Must have tried at least three different therapies, including specific types of drugs, or have disease resistant to these treatments.
  • For Phase 2: Must have tried at least three different therapies, including specific types of drugs, or have disease resistant to these treatments.
  • If previously treated with BCMA-directed CAR-T therapy, must have had a positive response and at least 60 days must have passed since that treatment.

Exclusion Criteria

  • Have certain other blood disorders or conditions like plasma cell leukemia or amyloidosis not related to myeloma.
  • Have brain lesions or cancer spread to the brain.
  • Have a heart function below 40%.
  • Have had certain previous treatments targeting BCMA, except for specific cases in Phase 2.
  • Have had a stem cell transplant from a donor at any time, or a self-donor transplant within 12 weeks before starting the study.

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