Autologous Transplantation and Maintenance Therapy in Multiple Myeloma
Open accessAbstract
BACKGROUND: This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma. METHODS: We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction, and 251 patients to lenalidomide maintenance therapy or no maintenance therapy. The primary end point was progression-free survival. RESULTS: The median follow-up period was 51.2 months. Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR (median progression-free survival, 43.0 months vs. 22.4 months; hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.32 to 0.61; P<0.001; and 4-year overall survival, 81.6% vs. 65.3%; hazard ratio for death, 0.55; 95% CI, 0.32 to 0.93; P=0.02). Median progression-free survival was significantly longer with lenalidomide maintenance than with no maintenance (41.9 months vs. 21.6 months; hazard ratio for progression or death, 0.47; 95% CI, 0.33 to 0.65; P<0.001), but 3-year overall survival was not significantly prolonged (88.0% vs. 79.2%; hazard ratio for death, 0.64; 95% CI, 0.36 to 1.15; P=0.14). Grade 3 or 4 neutropenia was significantly more frequent with high-dose melphalan than with MPR (94.3% vs. 51.5%), as were gastrointestinal adverse events (18.4% vs. 0%) and infections (16.3% vs. 0.8%); neutropenia and dermatologic toxic effects were more frequent with lenalidomide maintenance than with no maintenance (23.3% vs. 0% and 4.3% vs. 0%, respectively). CONCLUSIONS: Consolidation therapy with high-dose melphalan plus stem-cell transplantation, as compared with MPR, significantly prolonged progression-free and overall survival among patients with multiple myeloma who were 65 years of age or younger. Lenalidomide maintenance, as compared with no maintenance, significantly prolonged progression-free survival. (Funded by Celgene; ClinicalTrials.gov number, NCT00551928.).
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Lenalidomide is the standard of care for maintenance therapy for most patients with multiple myeloma.
“Lenalidomide is the standard of care for maintenance therapy for most patients.142–147”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [144]
The Discussion reports that lenalidomide maintenance prolonged progression-free survival compared with no maintenance in the trial’s newly diagnosed, transplant-eligible patients, with benefit in most studied subgroups. It does not establish lenalidomide as the standard of care for most patients with multiple myeloma; it also notes adverse effects and no significant overall-survival improvement in this trial. (LLM, conf=0.83)
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- Authors
- Palumbo, A., Cavallo, F., Gay, F., Di Raimondo, F., Ben Yehuda, D., Petrucci, M. T., Pezzatti, S., Caravita, T., Cerrato, C., Ribakovsky, E., Genuardi, M., Cafro, A., Marcatti, M., Catalano, L., Offidani, M., Carella, A. M., Zamagni, E., Patriarca, F., Musto, P., Evangelista, A., Ciccone, G., Omedé, P., Crippa, C., Corradini, P., Nagler, A., Boccadoro, M., & Cavo, M.
- Affiliations
- University of Catania (IT)
- University of Turin (IT)
- Sapienza University of Rome (IT)
- Azienda Ospedaliera San Gerardo (IT)
- University of Rome Tor Vergata (IT)
- Sheba Medical Center (IL)
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
- IRCCS Ospedale San Raffaele (IT)
- Federico II University Hospital (IT)
- Azienda Ospedaliero-Universitaria delle Marche (IT)
- Ospedale Policlinico San Martino (IT)
- University of Bologna (IT)
- University of Udine (IT)
- Centro di Riferimento Oncologico della Basilicata (IT)
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- University of Milan (IT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-09-04
- Volume
- 371
- Issue
- 10
- Pages
- 895-905
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2143425592
- Semantic Scholar
- 7d19f30319da069b72d035f4e86e2f9abd5de851
- Cited by
- 778
- References
- 26
- Citations by year
- 2026: 18 · 2025: 35 · 2024: 41 · 2023: 51 · 2022: 47 · 2021: 85 · 2020: 96 · 2019: 73 · 2018: 75 · 2017: 100 · 2016: 74 · 2015: 69 · 2014: 10 · 2013: 1
- FWCI
- 59.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- Institutional Research Information System (University of Udine) (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Hematology › Hematopoietic Stem Cell Transplantation
- Keywords
- multiple myeloma, autologous stem cell transplantation, high-dose melphalan, progression-free survival, overall survival, neutropenia, newly diagnosed multiple myeloma, consolidation therapy, adverse events, immunomodulators, proteasome inhibitors, lenalidomide
- MeSH terms
- Lenalidomide, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Humans, Melphalan, Middle Aged, Multiple Myeloma, Neutropenia, Prednisone, Thalidomide, Transplantation, Autologous, Disease-Free Survival, Antineoplastic Agents, Alkylating, Stem Cell Transplantation, Kaplan-Meier Estimate, Maintenance Chemotherapy, Consolidation Chemotherapy
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