M.D. Anderson Cancer Center
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.
Primary Objectives: * In Phase I, define the toxicities and recommended Phase II dose (RP2D) of belumosudil mesylate in a population of patients with relapsed/refractory multiple myeloma. * In Phase II, obtain preliminary evidence of efficacy of belumosudil mesylate and further expand the safety experience in this patient population. The overall response rate (ORR) will be defined using the International Myeloma Working Group Uniform Response Criteria as the proportion of patients who, on an intent-to-treat basis, achieve at least a partial response (PR) or better on either belumosudil mesyla…
Inclusion Criteria: * 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 (correct…
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