• Paul G Richardson, Susanna J Jacobus, Edie A Weller, Hani Hassoun, Sagar Lonial, Noopur S Raje, Eva Medvedova, Philip L McCarthy, Edward N Libby, Peter M Voorhees, Robert Z Orlowski, Larry D Anderson, Jeffrey A Zonder, Carter P Milner, Cristina Gasparetto, Mounzer E Agha, Abdullah M Khan, David D Hurd, Krisstina Gowin, Rammurti T Kamble, Sundar Jagannath, Nitya Nathwani, Melissa Alsina, R Frank Cornell, Hamza Hashmi, Erica L Campagnaro, Astrid C Andreescu, Teresa Gentile, Michaela Liedtke, Kelly N Godby, Adam D Cohen, Thomas H Openshaw, Marcelo C Pasquini, Sergio A Giralt, Jonathan L Kaufman, Andrew J Yee, Emma Scott, Pallawi Torka, Amy Foley, Mariateresa Fulciniti, Kyle Hebert, Mehmet K Samur, Kelly Masone, Michelle E Maglio, Andrea A Zeytoonjian, Omar Nadeem, Robert L Schlossman, Jacob P Laubach, Claudia Paba-Prada, Irene M Ghobrial, Aurore Perrot, Philippe Moreau, Hervé Avet-Loiseau, Michel Attal, Kenneth C Anderson, Nikhil C Munshi, and DETERMINATION Investigators.
• From the Department of Medical Oncology, Dana-Farber Cancer Institute, Jerome Lipper Multiple Myeloma Center (P.G.R., M.F., M.K.S., K.M., M.E.M., A.A.Z., O.N., R.L.S., J.P.L., C.P.-P., I.M.G., K.C.A., N.C.M.), the Department of Data Science, Dana-Farber Cancer Institute (S.J.J., K.H.), the Division of Hematology and Oncology, Boston Children's Hospital (E.A.W.), the Center for Multiple Myeloma, Massachusetts General Hospital (N.S.R., A.J.Y.), Harvard Medical School (P.G.R., S.J.J., E.A.W., N.S.R., A.J.Y.. M.F., K.H., M.K.S., K.M., M.E.M., A.A.Z., O.N., R.L.S., J.P.L., C.P.-P., I.M.G., K.C.A., N.C.M.), and the Veterans Affairs Boston Healthcare System (N.C.M.), Boston, and the Department of Medical Oncology, Davenport-Mugar Cancer Center, Cape Cod Hospital, Hyannis (T.H.O.) - all in Massachusetts; Myeloma Service, the Department of Medicine, Memorial Sloan Kettering Cancer Center (H. Hassoun, S.A.G.), and the Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai (S.J.), New York, the Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo (P.L.M., P.T.), and State University of New York Upstate Medical University, Syracuse (T.G.) - all in New York; the Winship Cancer Institute of Emory University, Atlanta (S.L., J.L.K.); Knight Cancer Institute, Oregon Health and Science University, Portland (E.M., E.S.); the Division of Medical Oncology and Fred Hutchinson Cancer Research Center, University of Washington, Seattle (E.N.L.); the Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte (P.M.V.), Duke University Medical Center, Durham (C.G.), and the Hematology and Oncology-Cancer Center, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem (D.D.H.) - all in North Carolina; the Department of Lymphoma and Myeloma, University of Texas M.D. Anderson Cancer Center (R.Z.O.), and Center for Cell and Gene Therapy, Baylor College of Medicine and Houston Methodist Hospital (R.T.K.), Houston, and Myeloma, Waldenstrom's, and Amyloidosis Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas (L.D.A.) - all in Texas; the Barbara Ann Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit (J.A.Z.), and the Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor (E.L.C.) - both in Michigan; the Division of Hematology and Oncology, University of Mississippi Medical Center, Jackson (C.P.M.); University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh (M.E.A.), and the Abramson Cancer Center, University of Pennsylvania, Philadelphia (A.D.C.) - both in Pennsylvania; the Division of Hematology, Ohio State University Comprehensive Cancer Center, Columbus (A.M.K.); the Department of Bone Marrow Transplant and Cellular Therapy, University of Arizona, Tucson (K.G.); Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte (N.N.), and the Department of Medicine, Division of Hematology, Stanford University, Stanford (M.L.) - both in California; the Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida (M. Alsina); Vanderbilt University Medical Center, Nashville (R.F.C.); the Division of Hematology Oncology, Medical University of South Carolina, Charleston (H. Hashmi); Northern Light Eastern Maine Medical Center Cancer Care, Brewer (A.C.A.), and the Cancer Care Center of Maine, Bangor (T.H.O.); O'Neal Comprehensive Cancer Center, the University of Alabama at Birmingham, Birmingham (K.N.G.); the Center for International Blood and Marrow Transplant Research (CIBMTR), Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee (M.C.P.); the National Marrow Donor Program, CIBMTR, Minneapolis (A.F.); and the Department of Hematology (A.P., M. Attal) and Unit for Genomics in Myeloma (H.A.-L.), Institut Universitaire du Cancer de Toulouse-Oncopole, University Hospital, Toulouse, and the Department of Hematology, University Hospital Hôtel-Dieu, Nantes (P.M.) - both in France.
• N. Engl. J. Med. 2022 Jul 14; 387 (2): 132147132-147.

BackgroundIn patients with newly diagnosed multiple myeloma, the effect of adding autologous stem-cell transplantation (ASCT) to triplet therapy (lenalidomide, bortezomib, and dexamethasone [RVD]), followed by lenalidomide maintenance therapy until disease progression, is unknown.MethodsIn this phase 3 trial, adults (18 to 65 years of age) with symptomatic myeloma received one cycle of RVD. We randomly assigned these patients, in a 1:1 ratio, to receive two additional RVD cycles plus stem-cell mobilization, followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Both groups received lenalidomide until disease progression, unacceptable side effects, or both. The primary end point was progression-free survival.ResultsAmong 357 patients in the RVD-alone group and 365 in the transplantation group, at a median follow-up of 76.0 months, 328 events of disease progression or death occurred; the risk was 53% higher in the RVD-alone group than in the transplantation group (hazard ratio, 1.53; 95% confidence interval [CI], 1.23 to 1.91; P<0.001); median progression-free survival was 46.2 months and 67.5 months. The percentage of patients with a partial response or better was 95.0% in the RVD-alone group and 97.5% in the transplantation group (P = 0.55); 42.0% and 46.8%, respectively, had a complete response or better (P = 0.99). Treatment-related adverse events of grade 3 or higher occurred in 78.2% and 94.2%, respectively; 5-year survival was 79.2% and 80.7% (hazard ratio for death, 1.10; 95% CI, 0.73 to 1.65).ConclusionsAmong adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed. (Funded by the National Heart, Lung, and Blood Institute and others; DETERMINATION ClinicalTrials.gov number, NCT01208662.).Copyright © 2022 Massachusetts Medical Society.

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