6/28/23, 12:41 AM ANDROMEDA Pathway Feedback Search Clinical Topics Home Studies ANDROMEDA ANDROMEDA Disease Immunoglobulin light chain amyl Trial question What is the role of daratumumab-based treatment in patients with newly diagnosed immunoglobulin light-chain amyloidosis? Study design Multi-center Open label RCT Population Characteristics of study participants 42.0% female N = 388 58.0% male 388 patients (163 female, 225 male) Inclusion criteria: patients with newly diagnosed immunoglobulin light-chain amyloidosis Key exclusion criteria: prior therapy for AL amyloidosis or multiple myeloma, previous or current diagnosis of symptomatic multiple myeloma, significant cardiovascular conditions, eGFR < 20 mL/min/1.73 m of BSA Interventions N=195 daratumumab (six cycles of bortezomib, cyclophosphamide, and dexamethasone with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles) N=193 control (six cycles of bortezomib, cyclophosphamide, and dexamethasone alone) https://web.pathway.md/studies/recdVitryZDdclzkp 1/2 6/28/23, 12:41 AM ANDROMEDA Pathway Primary outcome Hematologic complete response 53.3 % 53.3 40.0 % 26.6 % Significant increase 18.1 13.3 % NNT = 3 0.0 % Daratumumab Control Significant increase in hematologic complete response (53.3% vs. 18.1%; RR 2.9, 95% CI 2.1 to 4.1) Secondary outcomes Significant decrease in major organ deterioration or hematologic progression (17.4% vs. 27.5%; HR 0.58, 95% CI 0.36 to 0.93) Safety outcomes No significant differences in lymphopenia, cardiac failure, diarrhea, death. Conclusion In patients with newly diagnosed immunoglobulin light-chain amyloidosis, daratumumab was superior to control with respect to hematologic complete response. Reference Efstathios Kastritis, Giovanni Palladini, Monique C Minnema et al. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58. Open reference URL https://web.pathway.md/studies/recdVitryZDdclzkp 2/2