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Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma.

Publication ,  Journal Article
Richardson, PG; Jacobus, SJ; Weller, EA; Hassoun, H; Lonial, S; Raje, NS; Medvedova, E; McCarthy, PL; Libby, EN; Voorhees, PM; Orlowski, RZ ...
Published in: N Engl J Med
July 14, 2022

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. (Funded by the National Heart, Lung, and Blood Institute and others; DETERMINATION ClinicalTrials.gov number, NCT01208662.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 14, 2022

Volume

387

Issue

2

Start / End Page

132 / 147

Location

United States

Related Subject Headings

  • Transplantation, Autologous
  • Stem Cell Transplantation
  • Multiple Myeloma
  • Melphalan
  • Maintenance Chemotherapy
  • Lenalidomide
  • Humans
  • General & Internal Medicine
  • Disease-Free Survival
  • Disease Progression
 

Citation

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Richardson, P. G., Jacobus, S. J., Weller, E. A., Hassoun, H., Lonial, S., Raje, N. S., … DETERMINATION Investigators, . (2022). Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med, 387(2), 132–147. https://doi.org/10.1056/NEJMoa2204925
Richardson, Paul G., Susanna J. Jacobus, Edie A. Weller, Hani Hassoun, Sagar Lonial, Noopur S. Raje, Eva Medvedova, et al. “Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma.N Engl J Med 387, no. 2 (July 14, 2022): 132–47. https://doi.org/10.1056/NEJMoa2204925.
Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, et al. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132–47.
Richardson, Paul G., et al. “Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma.N Engl J Med, vol. 387, no. 2, July 2022, pp. 132–47. Pubmed, doi:10.1056/NEJMoa2204925.
Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, Medvedova E, McCarthy PL, Libby EN, Voorhees PM, Orlowski RZ, Anderson LD, Zonder JA, Milner CP, Gasparetto C, Agha ME, Khan AM, Hurd DD, Gowin K, Kamble RT, Jagannath S, Nathwani N, Alsina M, Cornell RF, Hashmi H, Campagnaro EL, Andreescu AC, Gentile T, Liedtke M, Godby KN, Cohen AD, Openshaw TH, Pasquini MC, Giralt SA, Kaufman JL, Yee AJ, Scott E, Torka P, Foley A, Fulciniti M, Hebert K, Samur MK, Masone K, Maglio ME, Zeytoonjian AA, Nadeem O, Schlossman RL, Laubach JP, Paba-Prada C, Ghobrial IM, Perrot A, Moreau P, Avet-Loiseau H, Attal M, Anderson KC, Munshi NC, DETERMINATION Investigators. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132–147.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 14, 2022

Volume

387

Issue

2

Start / End Page

132 / 147

Location

United States

Related Subject Headings

  • Transplantation, Autologous
  • Stem Cell Transplantation
  • Multiple Myeloma
  • Melphalan
  • Maintenance Chemotherapy
  • Lenalidomide
  • Humans
  • General & Internal Medicine
  • Disease-Free Survival
  • Disease Progression