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Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial : The Lancet Oncology
The Lancet Oncology - Online First, 10/23/09

Rajkumar SV et al. – Lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma.

Methods

Patients with untreated symptomatic myeloma randomly assigned in this open-label non-inferiority trial to lenalidomide 25 mg on days 1—21 plus dexamethasone 40 mg on days 1—4, 9—12, and 17—20 of a 28-day cycle (high dose), or lenalidomide given on same schedule with dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle (low dose)
After 4 cycles, patients could discontinue therapy to pursue stem-cell transplantation or continue treatment until disease progression
Primary endpoint was response rate after 4 cycles assessed with European Group for Blood and Bone Marrow Transplant criteria
Non-inferiority margin was absolute difference of 15% in response rate
Analysis was by modified intention to treat

Results

445 patients randomly assigned: 223 to high-dose and 222 to low-dose regimens. 169 (79%) of 214 patients receiving high-dose therapy and 142 (68%) of 205 patients on low-dose therapy had complete or partial response within four cycles
At second interim analysis at 1 year, overall survival was 96% (95% CI 94—99) in low-dose dexamethasone group compared with 87% (82—92) in the high-dose group
Trial was stopped and patients on high-dose therapy were crossed over to low-dose therapy
117 patients (52%) on high-dose regimen had grade 3 or worse toxic effects in first 4 months, compared with 76 (35%) of 220 on low-dose regimen for whom toxicity data were available , 12 of 222 on high dose and 1 of 220 on low-dose dexamethasone died in first 4 months
3 most common grade three or higher toxicities were deep-vein thrombosis, 57 (26%) of 223 versus 27 (12%) of 220 (p=0·0003); infections including pneumonia, 35 (16%) of 223 versus 20 (9%) of 220 , and fatigue 33 (15%) of 223 versus 20 (9%) of 220 , respectively

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