RecruitingMultiple Myeloma

Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: M.D. Anderson Cancer Center

You may qualify if…

✓ Patients must have had a histologically or cytologically confirmed diagnosis of symptomatic multiple myeloma at the time of their initial diagnosis, which requires the presence of all three of the following criteria:
✓ Clonal bone marrow plasma cells ≥10%, AND
✓ A monoclonal protein in either the serum or urine (except in subjects with non-secretory myeloma), AND
✓ Evidence of end-organ damage or a myeloma-defining event that can be attributed to the underlying plasma cell proliferative disorder (to include one or more of the following):
✓ Hypercalcemia (corrected calcium \>2.75 mmol/L or 11.5 mg/dL); OR
✓ Renal insufficiency attributable to myeloma (serum creatinine \> 1.9 mg/dL); OR
✓ Anemia; normochromic, normocytic with a hemoglobin value ≥2 g/dL below the lower limit of normal, or a hemoglobin or \<10 g/dL; OR
✓ Bone lytic lesions, severe osteopenia or pathologic fractures detected on a radiographic boney survey, OR

You may not qualify if…

✕ Patients who are receiving any concurrent investigational agent with known or suspected activity against multiple myeloma, or those whose adverse events due to chemotherapeutic/ immunologic agents or radiation therapy administered more than 2 weeks earlier have not recovered to a severity of grade 0 or grade 1, or to their pre-treatment baseline.
✕ Patients who have an ECOG \>2 will be excluded from this clinical trial because of their poor functional status which could confound the evaluation of adverse events unless this is felt to be disease-related and not from comorbid medical conditions.
✕ Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to belumosudil mesylate.
✕ Patients with known clinically active hepatitis A, B, and/or C infection, due to the difficulty that would be faced in assessing the attribution of any events of hepatic toxicity while on belumosudil mesylate therapy. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
✕ Uncontrolled intercurrent illness including not related to multiple myeloma, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, in the opinion of the Principal Investigator.
✕ The effects of belumosudil mesylate on the developing human fetus are unknown, and women of child-bearing potential and men must therefore agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
✕ Postmenopausal (no menses in greater than or equal to 12 consecutive months).
✕ History of hysterectomy or bilateral salpingo-oophorectomy.

Where it's recruiting

Texas

Houston

Source: ClinicalTrials.gov · NCT06105554 · last updated 2026-08-10