Long-term Results of Response to Therapy, Time to Progression, and Survival With Lenalidomide Plus Dexamethasone in Newly Diagnosed Myeloma

Lacy, Martha Q.; Gertz, Morie A.; Dispenzieri, Angela; Hayman, Suzanne R.; Geyer, Susan; Kabat, Brian; Zeldenrust, Steven R.; Kumar, Shaji; Greipp, Philip R.; Fonseca, Rafael; Lust, John A.; Russell, Stephen J.; Kyle, Robert A.; Witzig, Thomas E.; Bergsagel, P. Leif; Stewart, A. Keith; Rajkumar, S. Vincent
October 2007
Mayo Clinic Proceedings;Oct2007, Vol. 82 Issue 10, p1179
Academic Journal
OBJECTIVE: To determine the long-term effects of a combined regimen of lenalldomide 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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