Medical College of Wisconsin
This is a single-arm, open-label phase II study with a safety lead-in phase.
The study hypothesis is that the isatuximab plus bortezomib, cyclophosphamide and dexamethasone (VCD) combination is safe and highly effective even in those with renal insufficiency (RI) from myeloma. In this study, we seek to improve the efficacy of VCD by adding isatuximab in newly diagnosed multiple myeloma patients undergoing autologous stem cell transplant (ASCT) irrespective of renal function. The primary objective is to determine if the addition of isatuximab to VCD will increase the proportion of subjects achieving very good partial response (VGPR), as defined by the International Mye…
Inclusion Criteria: 1. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 2. Male or female subjects ≥18 years. 3. Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines. 4. No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m\^2) and/or cyclophosphamide up to 500 mg/m\^2…
Bortezomib (1.5 mg/m\^2) subcutaneous on days 1, 8 and 15
Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22
Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15
Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23
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