OBJECTIVE
To determine the long-term effects of a combined regimen of lenalidomide and dexamethasone
(Rev-Dex) on time to progression, progression-free survival, and overall survival
(OS) in patients with multiple myeloma.
PATIENTS AND METHODS
From March 2004 through October 2004, 34 patients were registered for the study. They
were treated with 25 mg/d of lenalidomide on days 1 through 21 of a 28-day cycle and
40 mg/d of dexamethasone on days 1 through 4, 9 through 12, and 17 through 20 of each
cycle. After 4 cycles of therapy, patients were allowed to discontinue treatment to
pursue autologous stem cell transplant (SCT). Treatment beyond 4 cycles was permitted
at the physician s discretion.
RESULTS
Thirteen patients proceeded to SCT after initial therapy and were censored at that
time point for purposes of calculation of response. Thirty-one patients achieved an
objective response, defined as a partial response or better (91%; 95% confidence interval,
79%-98%), with a complete response plus very good partial response rate of 56%. The
complete response plus very good partial response among the 21 patients who received
Rev-Dex without SCT was 67%. The 2-year progression-free survival rates for patients
proceeding to SCT and patients remaining on Rev-Dex were 83% and 59%, respectively;
the OS rates were 92% and 90% at 2 years and 92% and 85% at 3 years, respectively.
The 3-year OS rate for the whole cohort was 88%.
CONCLUSION
The Rev-Dex regimen is highly active in the treatment of newly diagnosed multiple
myeloma. Responses are durable with a low progression rate at 2 years. Randomized
trials that incorporate quality-of-life measures are needed to determine if this and
other combination regimens are better used early in therapy or should be reserved
for later interventions.
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© 2007 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
