![]() ![]() ![]() In both arms, patients were treated until disease progression or unacceptable toxicity. In the D-Rd arm, DARA was given at 16 mg/kg (intravenously) QW for Cycles 1-2, Q2W for Cycles 3-6, and Q4W thereafter. All patients received 28-day cycles of treatment with Rd ± DARA. Stratification was based on International Staging System stage (ISS ), region (North America vs other), and age (<75 vs ≥75 years). Patients ineligible for high-dose chemotherapy with autologous stem cell transplantation due to age ≥65 years or comorbidities were randomized 1:1 to Rd ± DARA. Here we report the prespecified interim analysis of the MAIA study. Based on the efficacy and tolerable safety profile of D-Rd, we conducted a phase 3 study (MAIA) to evaluate D-Rd vs Rd in transplant-ineligible NDMM. Of these, the POLLUX study with D-Rd showed the greatest benefit with a 63% reduction in risk of disease progression or death in patients with MM who had at least one prior line of therapy. As previously reported in 3 phase 3 studies, the addition of DARA to standards of care in both relapsed refractory (D-Rd, DARA plus bortezomib and dexamethasone ) or transplant-ineligible NDMM (DARA plus bortezomib, melphalan, and prednisone ) resulted in a ≥50% reduction in the risk of disease progression or death (Palumbo A, et al. Daratumumab (DARA) is a human, CD38-targeted, IgG1κ monoclonal antibody which has single-agent activity in heavily pretreated MM patients. Lenalidomide-based therapies are a standard of care for patients with newly diagnosed, transplant-ineligible MM. ![]()
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