Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma
Open accessAbstract
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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The DETERMINATION trial did not show a survival benefit with early ASCT.
“A more recent randomized trial in the United States (the DETERMINATION trial) also failed to demonstrate a survival benefit with early ASCT.96”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [96]
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- Authors
- Richardson, P. G., Jacobus, S. J., Weller, E. A., Hassoun, H., Lonial, S., Raje, N. S., Medvedova, E., McCarthy, P. L., Libby, E. N., Voorhees, P. M., Orlowski, R. Z., Anderson, L. D., Zonder, J. A., Milner, C. P., Gasparetto, C., Agha, M. E., Khan, A. M., Hurd, D. D., Gowin, K., Kamble, R. T., Jagannath, S., Nathwani, N., Alsina, M., Cornell, R. F., Hashmi, H., Campagnaro, E. L., Andreescu, A. C., Gentile, T., Liedtke, M., Godby, K. N., Cohen, A. D., Openshaw, T. H., Pasquini, M. C., Giralt, S. A., Kaufman, J. L., Yee, A. J., Scott, E., Torka, P., Foley, A., Fulciniti, M., Hebert, K., Samur, M. K., Masone, K., Maglio, M. E., Zeytoonjian, A. A., Nadeem, O., Schlossman, R. L., Laubach, J. P., Paba-Prada, C., Ghobrial, I. M., Perrot, A., Moreau, P., Avet-Loiseau, H., Attal, M., Anderson, K. C., & Munshi, N. C.
- Affiliations
- Boston Children's Hospital (US)
- Atrium Health Wake Forest Baptist (US)
- 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 Yo...
- ORCID
- Richardson, Paul G.
- Jacobus, Susanna J.
- Weller, Edie A.
- Hassoun, Hani
- Lonial, Sagar
- Raje, Noopur S.
- Medvedova, Eva
- McCarthy, Philip L.
- Voorhees, Peter M.
- Orlowski, Robert Z.
- Anderson, Larry D.
- Zonder, Jeffrey A.
- Gasparetto, Cristina
- Agha, Mounzer E.
- Khan, Abdullah M.
- Gowin, Krisstina
- Jagannath, Sundar
- Nathwani, Nitya
- Alsina, Melissa
- Cornell, R. Frank
- Hashmi, Hamza
- Campagnaro, Erica L.
- Gentile, Teresa
- Liedtke, Michaela
- Cohen, Adam D.
- Openshaw, Thomas H.
- Pasquini, Marcelo C.
- Giralt, Sergio A.
- Kaufman, Jonathan L.
- Yee, Andrew J.
- Scott, Emma
- Torka, Pallawi
- Foley, Amy
- Fulciniti, Mariateresa
- Samur, Mehmet K.
- Nadeem, Omar
- Laubach, Jacob P.
- Ghobrial, Irene M.
- Perrot, Aurore
- Moreau, Philippe
- Attal, Michel
- Anderson, Kenneth C.
- Munshi, Nikhil C.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-07-14
- Volume
- 387
- Issue
- 2
- Pages
- 132-147
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC10040899
- OpenAlex
- W4281628749
- Semantic Scholar
- 4abcef9a95ad1e8ca3472a13e7fd1e910f8e5f60
- Cited by
- 487
- References
- 38
- Citations by year
- 2026: 87 · 2025: 110 · 2024: 126 · 2023: 132 · 2022: 30
- FWCI
- 72.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- UA Campus Repository (The University of Arizona) (acceptedVersion)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- Funders
- Takeda Pharmaceuticals North America (N/a)
- RJ Corman Multiple Myeloma Research Fund (N/a)
- National Institutes of Health (Grants P01-155258 and 5P50 CA100707 (PGR, MKS, HA-)
- National Heart, Lung, and Blood Institute (U10HL069294 to the Blood and Marrow Transplant Cli)
- National Cancer Institute (U24HL138660 to the Blood and Marrow Transplant Cli)
- Celgene/Bristol Myers Squibb (N/a)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Amyloidosis: Diagnosis, Treatment, Outcomes
- Keywords
- multiple myeloma, autologous stem cell transplantation, lenalidomide, bortezomib, dexamethasone, high-dose melphalan, lenalidomide maintenance, progression-free survival, overall survival, newly diagnosed multiple myeloma, stem cell mobilization, treatment-related adverse events, complete response rate, disease progression
- MeSH terms
- Bortezomib, Lenalidomide, Adult, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Humans, Melphalan, Multiple Myeloma, Transplantation, Autologous, Disease Progression, Disease-Free Survival, Stem Cell Transplantation, Maintenance Chemotherapy
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