TY - JOUR
T1 - Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma
AU - Richardson, Paul G.
AU - Jacobus, Susanna J.
AU - Weller, Edie A.
AU - Hassoun, Hani
AU - Lonial, Sagar
AU - Raje, Noopur S.
AU - Medvedova, Eva
AU - McCarthy, Philip L.
AU - Libby, Edward N.
AU - Voorhees, Peter M.
AU - Orlowski, Robert Z.
AU - Anderson, Larry D.
AU - Zonder, Jeffrey A.
AU - Milner, Carter P.
AU - Gasparetto, Cristina
AU - Agha, Mounzer E.
AU - Khan, Abdullah M.
AU - Hurd, David D.
AU - Gowin, Krisstina
AU - Kamble, Rammurti T.
AU - Jagannath, Sundar
AU - Nathwani, Nitya
AU - Alsina, Melissa
AU - Cornell, R. Frank
AU - Hashmi, Hamza
AU - Campagnaro, Erica L.
AU - Andreescu, Astrid C.
AU - Gentile, Teresa
AU - Liedtke, Michaela
AU - Godby, Kelly N.
AU - Cohen, Adam D.
AU - Openshaw, Thomas H.
AU - Pasquini, Marcelo C.
AU - Giralt, Sergio A.
AU - Kaufman, Jonathan L.
AU - Yee, Andrew J.
AU - Scott, Emma
AU - Torka, Pallawi
AU - Foley, Amy
AU - Fulciniti, Mariateresa
AU - Hebert, Kyle
AU - Samur, Mehmet K.
AU - Masone, Kelly
AU - Maglio, Michelle E.
AU - Zeytoonjian, Andrea A.
AU - Nadeem, Omar
AU - Schlossman, Robert L.
AU - Laubach, Jacob P.
AU - Paba-Prada, Claudia
AU - Ghobrial, Irene M.
AU - Perrot, Aurore
AU - Moreau, Philippe
AU - Avet-Loiseau, Hervé
AU - Attal, Michel
AU - Anderson, Kenneth C.
AU - Munshi, Nikhil C.
N1 - Publisher Copyright:
Copyright © 2022 Massachusetts Medical Society.
PY - 2022/7/14
Y1 - 2022/7/14
N2 - BACKGROUND In 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. METHODS In 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. RESULTS Among 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). CONCLUSIONS Among adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed.
AB - BACKGROUND In 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. METHODS In 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. RESULTS Among 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). CONCLUSIONS Among adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed.
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U2 - 10.1056/NEJMoa2204925
DO - 10.1056/NEJMoa2204925
M3 - Article
C2 - 35660812
AN - SCOPUS:85134433277
SN - 0028-4793
VL - 387
SP - 132
EP - 147
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 2
ER -