Eastern Cooperative Oncology Group
This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles). After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.
2.1 Primary Objectives 2.1.1 To determine whether incorporation of daratumumab-hyaluronidase into the treatment algorithm for newly diagnosed light chain cast nephropathy (LCCN) will improve efficacy measured by renal response rates (RRR) per International Myeloma Working Group (IMWG) renal response criteria over 4 cycles of treatment. 2.2 Secondary Objectives 2.2.1 To evaluate the safety profile of daratumumab-hyaluronidase replacing cyclophosphamide in combination with bortezomib and dexamethasone and to compare treatment-related grades 3-5 adverse event rates based on CTCAE criteria 2.2.2…
3.1.1 Patient must be ≥ 18 years of age. 3.1.2 Patient must have an ECOG Performance Status 0-2. NOTE: ECOG Performance Status 3 patients are eligible if attributable to pathological fractures and/or cancer-related bone pain. 3.1.3 Patient must have multiple myeloma and meet BOTH of the following criteria for the original diagnosis of myeloma following the International Myeloma Working Group (IMWG) myeloma diagnostic criteria within 90 days prior to randomization. 1. Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma. Plasma cell % o…
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