Document Detail

Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance in untreated multiple myeloma patients.
MedLine Citation:
PMID:  20048187     Owner:  NLM     Status:  MEDLINE    
PURPOSE To evaluate the effect of bortezomib as induction therapy before autologous transplantation, followed by lenalidomide as consolidation-maintenance in myeloma patients. PATIENTS AND METHODS Newly diagnosed patients age 65 to 75 years were eligible. Induction (bortezomib, doxorubicin, and dexamethasone [PAD]) included four 21-day cycles of bortezomib (1.3 mg/m(2) on days 1, 4, 8, and 11), pegylated liposomal doxorubicin (30 mg/m(2) on day 4), and dexamethasone (40 mg/d; cycle 1: days 1 to 4, 8 to 11, and 15 to 18; cycles 2 to 4: days 1 to 4). Autologous transplantation was tandem melphalan 100 mg/m(2) (MEL100) and stem-cell support. Consolidation included four 28-day cycles of lenalidomide (25 mg/d on days 1 to 21 every 28 days) plus prednisone (50 mg every other day), followed by maintenance with lenalidomide (LP-L; 10 mg/d on days 1 to 21) until relapse. Primary end points were safety (incidence of grade 3 to 4 adverse events [AEs]) and efficacy (response rate). Results A total of 102 patients were enrolled. In a per-protocol analysis, after PAD, 58% of patients had very good partial response (VGPR) or better, including 13% with complete response (CR); after MEL100, 82% of patients had at least VGPR and 38% had CR; and after LP-L, 86% of patients had at least VGPR and 66% had CR. After median follow-up time of 21 months, the 2-year progression-free survival rate was 69%, and the 2-year overall survival rate was 86%. During induction, treatment-related mortality was 3%; grade 3 to 4 AEs included thrombocytopenia (17%), neutropenia (10%), peripheral neuropathy (16%), and pneumonia (10%). During consolidation-maintenance, grade 3 to 4 AEs were neutropenia (16%), thrombocytopenia (6%), pneumonia (5%), and cutaneous rash (4%). CONCLUSION Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance, is an effective regimen.
Antonio Palumbo; Francesca Gay; Patrizia Falco; Claudia Crippa; Vittorio Montefusco; Francesca Patriarca; Fausto Rossini; Simona Caltagirone; Giulia Benevolo; Norbert Pescosta; Tommasina Guglielmelli; Sara Bringhen; Massimo Offidani; Nicola Giuliani; Maria Teresa Petrucci; Pellegrino Musto; Anna Marina Liberati; Giuseppe Rossi; Paolo Corradini; Mario Boccadoro
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-01-04
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  28     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-09     Completed Date:  2010-03-04     Revised Date:  2010-04-30    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  800-7     Citation Subset:  IM    
Divisione di Ematologia dell'Universit? di Torino, Azienda Ospedaliero-Universitaria San Giovanni Battista, Via Genova 3, 10126 Torino, Italy.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Boronic Acids / administration & dosage
Chemotherapy, Adjuvant
Dexamethasone / administration & dosage
Disease-Free Survival
Doxorubicin / administration & dosage,  analogs & derivatives
Italy / epidemiology
Kaplan-Meiers Estimate
Melphalan / administration & dosage
Middle Aged
Multiple Myeloma / drug therapy*,  mortality,  surgery*
Neoadjuvant Therapy
Polyethylene Glycols / administration & dosage
Prednisone / administration & dosage
Protease Inhibitors / administration & dosage
Pyrazines / administration & dosage
Stem Cell Transplantation*
Thalidomide / administration & dosage,  analogs & derivatives
Time Factors
Transplantation, Autologous
Treatment Outcome
Reg. No./Substance:
0/Boronic Acids; 0/Polyethylene Glycols; 0/Protease Inhibitors; 0/Pyrazines; 0/bortezomib; 0/pegylated liposomal doxorubicin; 148-82-3/Melphalan; 191732-72-6/lenalidomide; 23214-92-8/Doxorubicin; 50-02-2/Dexamethasone; 50-35-1/Thalidomide; 53-03-2/Prednisone
Erratum In:
J Clin Oncol. 2010 May 1;28(13):2314

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