2024
A phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis.
Hagen P, Sidana S, Parker T, Walker B, Hoering A, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Ailawadhi S, Orlowski R. A phase III, randomized study of daratumumab, cyclophosphamide, bortezomib and dexamethasone (DARA-VCD) induction followed by autologous stem cell transplant or DARA-VCD consolidation and daratumumab maintenance in patients with newly diagnosed AL amyloidosis. Journal Of Clinical Oncology 2024, 42: tps7575-tps7575. DOI: 10.1200/jco.2024.42.16_suppl.tps7575.Peer-Reviewed Original ResearchAutologous stem cell transplantationProgression free survivalStem cell transplantationOverall survivalCell transplantationASCT armNext generation flow cytometryLight chain (AL) amyloidosisDaratumumab to bortezomibDiagnosed AL amyloidosisTwo-sided significance levelPlasma cell malignancyShort follow-upDaratumumab maintenanceMRD negativityFree survivalInduction therapyIntergroup trialMultiple myelomaAL amyloidosisHematologic responseRenal responseRandomized studyCell malignancyFollow-up
2020
A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Hagen P, Sarosiek S, Scott E, Hoering A, Durie B, Usmani S, Orlowski R. A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808). Blood 2020, 136: 20-21. DOI: 10.1182/blood-2020-143180.Peer-Reviewed Original ResearchPhase II studyAL amyloidosisJanssen BiotechEligible patientsCardiac involvementII studyComplete responsePartial responseGrade IAnti-CD38 monoclonal antibody therapyCommon drug-related AEsECOG performance status 0Overall hematologic response rateAutologous stem cell transplantMonoclonal antibodiesAdvisory CommitteeDrug-related AEsHematologic response ratePerformance status 0Relapsed refractory myelomaGood partial responseHigh-dose therapyProgression-free survivalRefractory multiple myelomaStage III disease