TY - JOUR
T1 - Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma
AU - Rajkumar, S. Vincent
AU - Hayman, Suzanne R.
AU - Lacy, Martha Q.
AU - Dispenzieri, Angela
AU - Geyer, Susan M.
AU - Kabat, Brian
AU - Zeldenrust, Steven R.
AU - Kumar, Shaji
AU - Greipp, Philip R.
AU - Fonseca, Rafael
AU - Lust, John A.
AU - Russell, Stephen J.
AU - Kyle, Robert A.
AU - Witzig, Thomas E.
AU - Gertz, Morie A.
PY - 2005/12/15
Y1 - 2005/12/15
N2 - 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. Forty-seven 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.
AB - 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. Forty-seven 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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U2 - 10.1182/blood-2005-07-2817
DO - 10.1182/blood-2005-07-2817
M3 - Article
C2 - 16118317
AN - SCOPUS:27744492561
SN - 0006-4971
VL - 106
SP - 4050
EP - 4053
JO - Blood
JF - Blood
IS - 13
ER -