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, Sanchorawala V, Zonder J, Kourelis T, D'Souza A, Landau H, Rosenthal A, Hoering 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. Blood 2024, 144: 3309.1-3309.1. DOI: 10.1182/blood-2024-208227.Peer-Reviewed Original ResearchAutologous stem cell transplantationNext generation flow cytometryStem cell transplantationOverall survivalConsolidation therapyAL amyloidCell transplantationASCT armLight chain (AL) amyloidosisSeverity of cardiac involvementFlow cytometryAL amyloid patientsDaratumumab to bortezomibTransplant related mortalityProgression free survivalHematologic response rateTwo-sided significance levelPlasma cell malignancyMulti-organ involvementDaratumumab maintenanceInduction therapyMRD negativityFree survivalIntergroup trialCardiac involvementIsatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott E, Hoering A, Durie B, Orlowski R. Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702). Blood 2024, 144: 3378-3378. DOI: 10.1182/blood-2024-208341.Peer-Reviewed Original ResearchMedian time to responseRelapsed AL amyloidosisTime to responseAL amyloidosisPartial responseHematologic responseComplete responseCardiac involvementOverall survivalRenal involvementOrgan involvementEastern Cooperative Oncology Group performance statusRate of hematologic responseAutologous stem cell transplantationProspective phase II trialLight chain (AL) amyloidosisDistribution of organ involvementProgression free survivalHematologic complete responseHematologic response rateStem cell transplantationPhase II trialAnti-CD38 antibodiesSystemic AL amyloidosisRate of patients
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