Multiple Myeloma Coverage from Every Angle

Venetoclax-Based Combination in Resistant Multiple Myeloma

By: Sarah Campen, PharmD
Posted: Monday, February 24, 2020

Nizar Bahlis, MD, of the Arnie Charbonneau Cancer Research Institute at the University of Calgary, Canada, and colleagues found that a combination regimen of venetoclax, daratumumab, and dexamethasone—either with or without the proteasome inhibitor bortezomib—appears to be an effective and tolerable treatment option for patients with relapsed or refractory multiple myeloma, including patients with a t(11;14) translocation. However, they reported that the study is currently on “partial clinical hold,” but previously enrolled patients continue to be followed. The findings of their two-part study were presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 925) and published in the journal Blood.

The phase I/II trial enrolled a total of 48 patients with relapsed or refractory multiple myeloma. In part 1, venetoclax, daratumumab, and dexamethasone were given to 24 patients carrying a t(11;14) translocation. Patients in part 1 had to have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory drug. In part 2 of the trial, 24 patients received venetoclax, daratumumab, dexamethasone, and bortezomib. This cohort included patients with or without a t(11;14) translocation who were not refractory to proteasome inhibitors.

The median follow-up in parts 1 and 2 was 3.6 and 3.1 months, and the objective response rate was 92% and 88%, respectively. As for safety, the most common adverse events observed in both cohorts were fatigue, diarrhea, nausea, and insomnia. Grade 3 or 4 adverse events were seen in 63% and 54% of patients in part 1 and 2, respectively. For patients in part 1, the most common grade 3 or 4 adverse events were neutropenia, fatigue, hyperglycemia, and hypertension; for patients in part 2, they were insomnia, diarrhea, and thrombocytopenia.

Disclosure: For full disclosures of study authors, visit

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