Phase I/II Study of Belumosudil Mesylate Alone and with Dexamethasone for Relapsed/Refractory Multiple Myeloma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06105554

Provider View

This clinical trial is testing a new drug, belumosudil mesylate, alone and in combination with dexamethasone, to see if it can help control multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study is divided into two phases. Phase I aims to find the safest dose of belumosudil mesylate for patients with relapsed or refractory multiple myeloma. Phase II will test if this dose can effectively control the disease. The trial will also explore how well the drug works when combined with dexamethasone, a steroid medication.

Description

The main goals of this study are to determine the safest dose of belumosudil mesylate and to see if it can help control multiple myeloma that has returned or not responded to previous treatments. In Phase I, researchers will focus on identifying any side effects and the best dose to use in Phase II. In Phase II, they will look at how well the drug works alone and with dexamethasone, measuring how many patients experience a reduction in their cancer.

Secondary goals include examining how many patients experience at least a minimal response to the treatment, how long the responses last, and how the treatment affects patients' quality of life. Researchers will also study the impact of the treatment on the cancer cells and the surrounding environment in the body.

The study will involve collecting bone marrow samples to analyze changes in the cancer cells and immune system. This will help researchers understand how the drug works and identify any potential markers that could predict treatment success.

Participants will need to meet specific health criteria to join the study, including having a confirmed diagnosis of multiple myeloma, measurable disease, and having tried at least three previous treatments. They must also be in good overall health, with adequate blood counts and organ function.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of symptomatic multiple myeloma with specific criteria, including:
    • Clonal bone marrow plasma cells ≥10%.
    • A monoclonal protein in the blood or urine.
    • Evidence of organ damage related to myeloma, such as high calcium levels, kidney issues, anemia, or bone damage.
  • Must have measurable disease, such as a certain level of monoclonal protein in the blood or urine.
  • Must have tried at least three previous treatments for multiple myeloma.
  • Must be 18 years or older and able to provide informed consent.
  • Must have good overall health, with adequate blood counts and organ function.
  • Must agree to use effective contraception during the study and for a period after.

Exclusion Criteria

  • Cannot be taking any other investigational drugs for multiple myeloma.
  • Cannot have severe side effects from previous treatments that have not resolved.
  • Cannot have a known allergy to similar drugs.
  • Cannot have active hepatitis or other serious infections.
  • Cannot have uncontrolled health conditions, such as heart failure or psychiatric illness.
  • Cannot be pregnant or breastfeeding.
  • Cannot have another active cancer or a history of certain other cancers.
  • Cannot have active plasma cell leukemia or POEMS syndrome.
  • Cannot have required recent plasmapheresis.
  • Cannot be HIV positive and on antiretroviral therapy.
  • Cannot have active central nervous system involvement with multiple myeloma.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.