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Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232).

Author(s): Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF Sr, Whittenberger BF, Abidi MH, Durie BG, Barlogie B

Affiliation(s): Karmanos Cancer Institute, Wayne State University, Detroit, MI, United States;

Publication date & source: 2010-09-27, Blood., [Epub ahead of print]

The Southwest Oncology Group (SWOG) conducted a randomized trial comparing lenalidomide (LEN) plus dexamethasone (DEX) (n=97) to placebo (PLC) plus DEX (n=95) in newly diagnosed myeloma. Three 35-day induction cycles applied DEX 40 mg/day on days 1-4, 9-12, 17-20 together with LEN 25mg/d for 28 days or PLC. Monthly maintenance employed DEX 40mg/d on days 1-4 and 15-18 along with LEN 25mg/d for 21 days or PLC. Cross-over from PLC-DEX to LEN-DEX was encouraged upon progression. One-year progression-free survival, overall response rate, and very good partial response rate were superior with LEN-DEX (78% v 52%, p=0.002; 78% v 48%, p<0.001; 63% v 15%, p< 0.001), while 1-year overall survival was similar (94% v 88%; p=0.25). Toxicities were more pronounced with LEN-DEX (neutropenia grade 3-4: 21% v 5%, p=<0.001; thromboembolic events despite aspirin prophylaxis: 23.5% [initial LEN-DEX or cross-over] v 5%; p=<0.001). This trial was registered at www.clinicaltrials.gov as #NCT00064038.

Page last updated: 2010-10-05

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