Bortezomib and thalidomide maintenance after stem cell transplantation for multiple myeloma: a PETHEMA/GEM trial

The phase III trial GEM05MENOS65 randomized 390 patients 65 years old or younger with newly diagnosed symptomatic multiple myeloma (MM) to receive induction with thalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone and Vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine...

Full description

Saved in:

Bibliographic Details
Published in:	Leukemia Vol. 31; no. 9; pp. 1922 - 1927
Main Authors:	Rosiñol, L, Oriol, A, Teruel, A I, de la Guía, A L, Blanchard, MaJ, de la Rubia, J, Granell, M, Sampol, MaA, Palomera, L, González, Y, Etxebeste, MaA, Martínez-Martínez, R, Hernández, M T, de Arriba, F, Alegre, A, Cibeira, MaT, Mateos, MaV, Martínez-López, J, Lahuerta, J J, San Miguel, J, Bladé, J
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 01-09-2017 Nature Publishing Group
Subjects:	692/308/2779/109 692/699 692/699/1541/1990 692/699/67/1059/2325 692/699/67/1990/804 692/700/565/545/576/1955 Autografts Bortezomib Bortezomib - administration & dosage Cancer Research Care and treatment Critical Care Medicine Cyclophosphamide Dexamethasone Disease-Free Survival Dosage and administration Doxorubicin Female Hematology Hematopoietic Stem Cell Transplantation - methods Humans Inhibitor drugs Intensive Interferon Interferon-alpha - therapeutic use Internal Medicine Intravenous administration Maintenance Maintenance Chemotherapy - methods Male Medicine Medicine & Public Health Melphalan Middle Aged Multiple myeloma Multiple Myeloma - complications Multiple Myeloma - mortality Multiple Myeloma - therapy Oncology original-article Patients Peripheral Nervous System Diseases - chemically induced Peripheral neuropathy Prednisone Product development Randomization Stem cell transplantation Stem cells Survival Survival Rate Targeted cancer therapy Thalidomide Thalidomide - administration & dosage Transplantation Vincristine
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	The phase III trial GEM05MENOS65 randomized 390 patients 65 years old or younger with newly diagnosed symptomatic multiple myeloma (MM) to receive induction with thalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone and Vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, doxorubicin, dexamethasone bortezomib (VBMCP/VBAD/B) followed by autologous stem cell transplantation (ASCT) with MEL-200. After ASCT, a second randomization was performed to compare thalidomide/bortezomib (TV), thalidomide (T) and alfa-2b interferon (alfa2-IFN). Maintenance treatment consisted of TV (thalidomide 100 mg daily plus one cycle of intravenous bortezomib at 1.3 mg/m 2 on days 1, 4, 8 and 11 every 3 months) versus T (100 mg daily) versus alfa2-IFN (3 MU three times per week) for up to 3 years. A total of 271 patients were randomized (TV: 91; T: 88; alfa2-IFN: 92). The complete response (CR) rate with maintenance was improved by 21% with TV, 11% with T and 17% with alfa2-IFN ( P , not significant). After a median follow-up of 58.6 months, the progression-free survival (PFS) was significantly longer with TV compared with T and alfa2-IFN (50.6 vs 40.3 vs 32.5 months, P =0.03). Overall survival was not significantly different among the three arms. Grade 2–3 peripheral neuropathy was observed in 48.8%, 34.4% and 1% of patients treated with TV, T and alfa2-IFN, respectively. In conclusion, bortezomib and thalidomide maintenance resulted in a significantly longer PFS when compared with thalidomide or alfa2-IFN. (no. EUDRA 2005-001110-41).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23
ISSN:	0887-6924 1476-5551
DOI:	10.1038/leu.2017.35