Actively Recruiting
Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma
Led by M.D. Anderson Cancer Center · Updated on 2026-02-18
36
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sanofi US Services, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1 is to find the recommended dose of belumosudil mesylate that can be given to patients with relapsed/refractory MM. Phase 2 is to learn if the dose of belumosudil mesylate found in Phase 1 can help to control the disease.
CONDITIONS
Official Title
Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed symptomatic multiple myeloma diagnosis
- Presence of clonal bone marrow plasma cells ≥10%, monoclonal protein in serum or urine (except non-secretory myeloma), and evidence of end-organ damage or myeloma-defining event
- Measurable disease by serum or urine monoclonal protein levels or bone marrow involvement
- Relapsed or refractory multiple myeloma with at least three prior lines of therapy including proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody or equivalent intolerance
- Completed radiation therapy and corticosteroids at least 2 weeks before starting study treatment
- Age 18 years or older and able to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (or 3 if due to disease symptoms)
- Adequate bone marrow, liver, cardiac, and renal function as defined by specific laboratory thresholds
- HIV-positive patients not on combination antiretroviral therapy with acceptable organ function and CD4+ count >1,000 cells/mm3
- Agreement to use effective contraception if applicable
You will not qualify if you...
- Receiving other investigational agents with activity against multiple myeloma or unresolved adverse events from prior treatments
- ECOG performance status greater than 2 unless disease-related
- Known allergies to compounds similar to belumosudil mesylate
- Active hepatitis A, B, or C infections with detectable viral load or untreated disease
- Uncontrolled illnesses including infections, heart failure, angina, arrhythmia, or psychiatric/social issues affecting compliance
- Pregnant or breastfeeding women
- Active second malignancy, except certain treated cancers without progression
- Active plasma cell leukemia or POEMS syndrome
- Recent plasmapheresis within 2 weeks before treatment
- HIV-positive patients on combination antiretroviral therapy
- Known active central nervous system involvement with multiple myeloma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Robert Orlowski, M D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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