Conference Correspondent

Pomalidomide/Dexamethasone/Ixazomib versus Pomalidomide/Dexamethasone in Patients with RRMM

Conference Correspondent 

The phase 1/2 Alliance study A061202 evaluated the safety and preliminary efficacy of the addition of the oral proteasome inhibitor ixazomib to the approved pomalidomide and dexamethasone combination versus pomalidomide and dexamethasone in patients with double-refractory multiple myeloma (MM); Voorhees and colleagues reported on the phase 1 results of the study.1

In the phase 1 part of the study, 22 patients on 4 dose cohorts received pomalidomide (2‑4 mg; days 1- 21) plus ixazomib (3-4 mg; days 1, 8, and 15) and dexamethasone (40 mg; days 1, 8, 15, and 22) on a 3+3 dose-escalation design. All 22 patients were double refractory to bortezomib and lenalidomide. Overall, 2 dose-limiting toxicities of febrile neutropenia were reported, 1 each at dose levels 3 and 4. The safety analysis showed that grade 3/4 adverse events (AEs) were limited to hematologic toxicities, including neutropenia, thrombocytopenia , anemia, and lymphopenia; grade 3 infection was reported in 12% of patients. Nonhematologic toxicities were uncommon and mostly mild or moderate in severity. Treatment-related peripheral neuropathy (≤grade 2) occurred in 8 patients. More than half (50%) of the patients reported dose reductions in at least 1 of the 3 drugs, as well as dose delays. Treatment discontinuations due to AEs were reported in 2 patients, 1 due to grade 2 peripheral neuropathy and 1 due to grade 4 neutropenia. Currently, enrollment into dose level 4 (4 mg of pomalidomide and 4 mg of ixazomib) is ongoing. Of 20 patients evaluable for efficacy, the best overall response rate was 55%, including partial responses in 50% of patients, and very good partial responses in 5% of patients. Based on these results, the authors concluded that the combination of ixazomib, pomalidomide, and dexamethasone showed promising activity accompanied by an acceptable toxicity profile in heavily pretreated double-refractory patients with MM, and that the observed hematologic toxicities were manageable with close monitoring and supportive care.

  1. Voorhees PM, et al. ASH 2015. Abstract 375.

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