Marizomib May Be Active in Relapsed, Refractory Myeloma

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Marizomib was generally well tolerated and may have clinical activity in previously treated, relapsed or refractory multiple myeloma.
Marizomib was generally well tolerated and may have clinical activity in previously treated, relapsed or refractory multiple myeloma.

Marizomib, a novel, irreversible proteasome inhibitor distinct from bortezomib and carfilzomib, was generally well tolerated and may have clinical activity in previously treated, relapsed or refractory multiple myeloma, a study published in the journal Blood has shown.1

For the phase 1 portion of this study, researchers sought to determine a maximum tolerated dose and recommended phase 2 dose.

Researchers enrolled 68 patients with relapsed/refractory multiple myeloma and assigned 32 to receive marizomib 0.025–0.7 mg/m2 IV once weekly on days 1, 8, 15 of 4-week cycles (schedule A) or 0.15–0.6 mg/m2 twice weekly on days 1, 4, 8, 11 of 3-week cycles schedule B). Patients in the schedule B group were eligible to receive concomitant dexamethasone, as well.

Researchers ultimately determined that 0.7 mg/m2 infused over 10 minutes and 0.5 mg/m2 infused over 2 hours would be the recommended phase 2 doses for schedule A and B, respectively.

On average, patients in the schedule A group had received approximately 5 prior treatment regimens and those in the schedule B group had received about 7 prior regimens.

Results showed the most frequently reported treatment-related adverse events were fatigue, headache, nausea, diarrhea, dizziness, and vomiting.

In terms of efficacy, 6 patients achieved a clinical benefit response. Of those, 5 had partial responses: 1 patient receiving schedule A and 4 on schedule B. Three of the 4 on schedule B were receiving concomitant dexamethasone. Further, these responses were in patients who had received prior bortezomib, lenalidomide, and/or thalidomide.

RELATED: FDA Approves New Melphalan Formulation for the Treatment of Multiple Myeloma

The findings suggest activity of marizomib in this heavily treated population with a minimal number of dose-limiting toxicities. Studies evaluating marizomib in combination with pomalidomide and dexamethasone are currently underway.

Reference

  1. Richardson PG, Zimmerman TM, Hofmeister CC, et al. Phase 1 study of marizomib in relapsed or relapsed and refractory multiple myeloma; NPI 0052 101 Part 1 [published online ahead of print March 23, 2016]. Blood. doi: 10.1182/blood-2015-12-686378.

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