M.D. Anderson Cancer Center
To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).
Objectives: Primary Objectives 1\. Compare progression-free survival at 3 years with historical control rate of 50%. Primary endpoint 1\. Progression-free survival at 3 years, measured from the date of transplant to the date of progression or death. Secondary objectives: 1. Assess minimal residual disease (MRD) rate at 12 months after starting Isatuximab maintenance therapy 2. Assess overall best response rate (defined as the occurrence of VGPR or better and CR/sCR) before the 4th Isatuximab cycle, and at 12, 24, and 36 months after starting maintenance therapy 3. Assess MRD rate before…
Inclusion Criteria: 1. Adult patients 18 to 72 years old, with newly diagnosed symptomatic (according to the revised 2014 IMWG criteria as summarized in Appendix A) myeloma. Patients must have measurable disease at diagnosis defined by any of the following: * Serum M-protein ≥1 g/dL (for IgA ≥0.5 g/dL) or urine M-protein ≥200 mg/24 hours * For oligosecretory myeloma, involved serum free light chain (FLC) level ≥10 mg/dL, provided serum FLC ratio is abnormal * For non-secretory myeloma, \> 1 focal lesions measurable by imaging 2. Subjects must have high-risk myeloma defined as follow…
Given by vein over about 75 minutes
Given by PO
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