Yazarlar : Leleu X, Attal M, Arnulf B

Yayın : Blood.

Yayın Yılı : 2013

Konu : Myelom

Literatür İçeriği : The combination of pomalidomide and dexamethasone can be safely administered to Multiple Myeloma (MM) and has significant efficacy although the optimal regimen remains to be determined. MM who progressed after multiple lines of therapy have limited treatment options. We designed a multicenter phase 2 randomized study assessing 2 different dose regimens of pomalidomide and dexamethasone in advanced MM. Treatment response was assessed centrally. Pomalidomide (4 mg) was given orally on days 1 to 21 (arm 21/28) or continuously (arm 28/28) over a 28-day cycle, plus Dexamethasone given weekly. Eighty four patients (43 arm 21/28 and 41 arm 28/28) were randomized. The median number of prior lines was 5. ORR was 35% (arm 21/28) and 34% (arm 28/28), independent of the number of prior lines and level of refractoriness. Median DOR, TTP and PFS was 7.3, 5.4 and 4.6 months, similar across cohorts. At 23 months follow up, median OS was 14.9 months, with 44% of the patients alive at 18 months. Toxicity consisted primarily of myelosuppression, which was manageable. The efficacy and safety data presented here, along with data from other phase 2 trials, suggest that pomalidomide 4 mg/day on days 21/28 with dexamethasone should be investigated in future trials. This trial is registered at ClinicalTrials.gov (No. NCT01053949).

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