![]() In 24 evaluable pts, ORR (CR/nCR+VGPR+PR+MR) is currently 79%, including 33% CR/nCR/VGPR.Ĭonclusions: RVD is very active in pts with relapsed and/or refractory MM, including pts with prior Rev, Vel, thalidomide, and SCT. G3 PN was reported in only 1 pt despite Vel dose reduction, resulting in treatment discontinuation. Two episodes of atrial fibrillation (G3) were reported, reversed with cardiac medication, attributed to Rev/Dex, prompted Dex dose reduction and have not recurred. Enoxaparin and Coumadin were administered and the pt continued on therapy. Attributable non-hematologic toxicities included 1 DVT in the context of air travel in a pt who had been receiving aspirin 81mg as thromboprophylaxis. Toxicities were manageable and consisted primarily of G1-2 myelosuppression. Dose reductions were required for Rev in 4, Vel in 4 and Dex in 11 pts. Pts received a median of 7 cycles (range 1–15) 10 pts completed 8 cycles and 5 pts continued on maintenance. of prior therapies was 2 (range 1–3), including prior SCT in 7, prior Vel in 18, prior Rev in 1, prior thalidomide in 21 and prior Dex in 22 pts. ![]() Median age was 71 yrs (range 51–83) and median no. Results: 27 pts (19 men, 8 women) have been enrolled to date, including 16 with relapsed and 11 with relapsed and refractory MM. Response was assessed according to modified EBMT and Uniform criteria with toxicities assessed using NCI CTCAE v3.0. Pts received concomitant antithrombotic and antiviral prophylaxis. After cycle 8, pts with stable or responding disease were allowed to continue on a maintenance schedule with Vel (d 1 and 8) and Rev (d 1–14) at the dose levels tolerated at the end of cycle 8, with Dex at 10mg (d 1, 2, 8, 9). Methods: Pts with relapsed/refractory MM and 1–3 prior lines of therapy received up to eight 21-d cycles of Vel 1.0mg/m2, d 1, 4, 8, 11, Rev 15mg, d 1–14 of a 21-d cycle, and Dex 40mg (cycles 1–4)/20mg (cycles 5–8), days of/after Vel dosing. The aim of this multicenter phase 2 study was to evaluate the efficacy and safety of Rev/Vel/Dex (RVD) at the phase-1 MTD in up to 64 relapsed and/or refractory MM pts. In a phase 1 study, Rev/Vel (MTD 1.0mg/m2/15mg) ± Dex (20–40mg) was well tolerated and resulted in a response rate (CR+PR+MR) of 58% in relapsed and/or refractory MM pts. ![]() Preclinical studies show Rev sensitizes MM cells to Vel and Dex, suggesting combination therapy may enhance clinical activity. DEX ONLINE CHICAGO PLUSBackground: Single-agent bortezomib (VELCADE®, Vel) and lenalidomide (Revlimid®, Rev) plus dexamethasone (Dex) are approved for relapsed MM patients (pts) following ≥1 prior therapy. ![]()
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