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Blood, 15 December 2005, Vol. 106, No. 13, pp. 4050-4053.
Prepublished online as a Blood First Edition Paper on August 23, 2005; DOI 10.1182/blood-2005-07-2817.


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CLINICAL TRIALS AND OBSERVATIONS

Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma

S. Vincent Rajkumar, Suzanne R. Hayman, Martha Q. Lacy, Angela Dispenzieri, Susan M. Geyer, Brian Kabat, Steven R. Zeldenrust, Shaji Kumar, Philip R. Greipp, Rafael Fonseca, John A. Lust, Stephen J. Russell, Robert A. Kyle, Thomas E. Witzig, and Morie A. Gertz

From the Divisions of Hematology and Biostatistics, Mayo Clinic, Rochester, MN; and the Division of Hematology/Oncology, Mayo Clinic, Scottsdale, AZ.

We report the results of a phase 2 trial using lenalidomide plus dexamethasone (Rev/Dex) as initial therapy for myeloma. Thirtyfour patients were enrolled. Lenalidomide was given orally 25 mg daily on days 1 to 21 of a 28-day cycle. Dexamethasone was given orally 40 mg daily on days 1 to 4, 9 to 12, and 17 to 20 of each cycle. Objective response was defined as a decrease in serum monoclonal protein level by 50% or greater and a decrease in urine M protein level by at least 90% or to a level less than 200 mg/24 hours, confirmed by 2 consecutive determinations at least 4 weeks apart. Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good partial response and near complete response, resulting in an overall objective response rate of 91%. Of the 3 remaining patients not achieving an objective response, 2 had minor response (MR) and one had stable disease. Fortyseven percent of patients experienced grade III or higher nonhematologic toxicity, most commonly fatigue (15%), muscle weakness (6%), anxiety (6%), pneumonitis (6%), and rash (6%). Rev/Dex is a highly active regimen with manageable side effects in the treatment of newly diagnosed myeloma.


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Related Article in Blood Online:

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