Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
26729895
DOI
10.1182/blood-2015-08-662627
PII: S0006-4971(20)30393-1
Knihovny.cz E-resources
- MeSH
- Demography MeSH
- Kaplan-Meier Estimate MeSH
- Drug Therapy, Combination MeSH
- Lenalidomide MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Myeloma diagnosis drug therapy MeSH
- Follow-Up Studies MeSH
- Disease-Free Survival MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Thalidomide adverse effects analogs & derivatives therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Lenalidomide MeSH
- Thalidomide MeSH
Lenalidomide-dexamethasone improved outcome in newly diagnosed elderly multiple myeloma patients. We randomly assigned 662 patients who were age ≥65 years or transplantation-ineligible to receive induction with melphalan-prednisone-lenalidomide (MPR) or cyclophosphamide-prednisone-lenalidomide (CPR) or lenalidomide plus low-dose dexamethasone (Rd). The primary end point was progression-free survival (PFS) in triplet (MPR and CPR) vs doublet (Rd) lenalidomide-containing regimens. After a median follow-up of 39 months, the median PFS was 22 months for the triplet combinations and 21 months for the doublet (P = .284). The median overall survival (OS) was not reached in either arms, and the 4-year OS was 67% for the triplet and 58% for the doublet arms (P = .709). By considering the 3 treatment arms separately, no difference in outcome was detected among MPR, CPR, and Rd. The most common grade ≥3 toxicity was neutropenia: 64% in MPR, 29% in CPR, and 25% in Rd patients (P < .0001). Grade ≥3 nonhematologic toxicities were similar among arms and were mainly infections (6.5% to 11%), constitutional (3.5% to 9.5%), and cardiac (4.5% to 6%), with no difference among the arms. In conclusion, in the overall population, the alkylator-containing triplets MPR and CPR were not superior to the alkylator-free doublet Rd, which was associated with lower toxicity. This study was registered at www.clinicaltrials.gov as #NCT01093196.
Azienda Ospedaliera S Maria di Terni SC Oncoematologia Terni Italy;
Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy;
Department of Medicine Hematology and Clinical Immunology Padua School of Medicine Padua Italy;
Division of Hematology Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy; and
Divisione di Medicina Interna ed Ematologia AOU San Luigi Gonzaga Orbassano Italy;
Emat CTMO Ospedale R Binaghi Cagliari Cagliari Italy;
Unità Operativa Complessa Ematologia Azienda Ospedaliera Universitaria G Martino Messina Italy;
References provided by Crossref.org
Epidemiology, genetics and treatment of multiple myeloma and precursor diseases
ClinicalTrials.gov
NCT01093196
