Document Detail


A phase III randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with asymptomatic multiple myeloma.
MedLine Citation:
PMID:  22902362     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Patients with asymptomatic (smoldering) multiple myeloma (AMM) have a high risk of transformation to active multiple myeloma (MM). Bisphosphonates such as zoledronic acid (ZLD) reduce skeletal events in MM and the immunomodulatory agent thalidomide (Thal) has proven effectiveness in active MM. We hypothesized that treatment with Thal and ZLD would prolong the time to progression (TTP) to MM over ZLD alone. Eligible patients had asymptomatic MM and all patients received ZLD 4 mg intravenous monthly; the treatment arm also received Thal 200 mg per day. The TTP was superior for Thal/ZLD (n=35) patients compared with ZLD alone (n=33); median TTP of 2.4 years (95% confidence interval (CI): 1.4-3.6) versus 1.2 years (95% CI: 0.7-2.5) (hazard ratio (HR), 2.05; 95% CI: 1.1-3.8; P-value: 0.02). At 1 year, 86% of Thal/ZLD patients were progression free compared with 55% on ZLD alone (P=0.0048). The overall response rate after year 1 was 37% for Thal/ZLD with a median duration of response of 3.3 years (95% CI: 1.1-NA); there were no confirmed responses to ZLD alone (P=0.0004). The addition of Thal to standard ZLD produces anti-tumor responses whereas ZLD alone does not. Thal/ZLD also prolongs TTP from AMM to MM. This study provides the rationale for further studies in patients with AMM to delay chemotherapy.
Authors:
T E Witzig; K M Laumann; M Q Lacy; S R Hayman; A Dispenzieri; S Kumar; C B Reeder; V Roy; J A Lust; M A Gertz; P R Greipp; H Hassoun; S J Mandrekar; S V Rajkumar
Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-08-20
Journal Detail:
Title:  Leukemia     Volume:  27     ISSN:  1476-5551     ISO Abbreviation:  Leukemia     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-09     Completed Date:  2013-02-28     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  8704895     Medline TA:  Leukemia     Country:  England    
Other Details:
Languages:  eng     Pagination:  220-5     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00432458
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Bone Density Conservation Agents / therapeutic use*
Diphosphonates / therapeutic use*
Disease Progression
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Imidazoles / therapeutic use*
Immunosuppressive Agents / therapeutic use*
Male
Middle Aged
Multiple Myeloma / drug therapy*,  mortality,  pathology
Neoplasm Staging
Prognosis
Survival Rate
Thalidomide / therapeutic use*
Grant Support
ID/Acronym/Agency:
R01 CA100080/CA/NCI NIH HHS; R01CA100080/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Bone Density Conservation Agents; 0/Diphosphonates; 0/Imidazoles; 0/Immunosuppressive Agents; 118072-93-8/zoledronic acid; 4Z8R6ORS6L/Thalidomide
Comments/Corrections

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