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-upA 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 PA145 (#114)
Hagen P, Hoering A, Sidana S, Parker T, Walker B, Sanchorawala V, Zonder J, Kourelis T, D’Souza A, Landau H, Rosenthal A, Ailawadhi S, Z. 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 PA145 (#114). 2024 DOI: 10.26226/m.65f9bf89e6f73964e1d4eb32.Peer-Reviewed Original Research
2020
Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial
Kumar SK, Jacobus SJ, Cohen AD, Weiss M, Callander N, Singh AK, Parker TL, Menter A, Yang X, Parsons B, Kumar P, Kapoor P, Rosenberg A, Zonder JA, Faber E, Lonial S, Anderson KC, Richardson PG, Orlowski RZ, Wagner LI, Rajkumar SV. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. The Lancet Oncology 2020, 21: 1317-1330. PMID: 32866432, PMCID: PMC7591827, DOI: 10.1016/s1470-2045(20)30452-6.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantationProgression-free survivalStem cell transplantationVRd regimenInduction therapyMultiple myelomaVRd groupDay 1Oral lenalidomideOral dexamethasoneOverall survivalEastern Cooperative Oncology Group performance statusMedian progression-free survivalNon-haematological adverse eventsSecond planned interim analysisNext-generation proteasome inhibitorsHigh-risk multiple myelomaCommon grade 3Treatment-related deathsMedian overall survivalPhase 2 trialCommunity oncology practicesStandard of careKey inclusion criteriaPhase 3