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Venetoclax
Source: Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Venetoclax is a selective BCL-2 inhibitor that induces apoptosis in myeloma cells, particularly in those with t(11;14), which expresses high levels of bcl2.
Evidence (venetoclax):
In a phase I study of 66 heavily pretreated patients with relapsed or refractory myeloma, 30 patients harbored a t(11;14) translocation.[90]
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In a phase I study of 66 heavily pretreated patients with relapsed or refractory myeloma, 30 patients harbored a t(11;14) translocation.[90]
Among all 66 patients, the overall response rate was 21%, and 15% of patients achieved very good partial response or better. For those with t(11;14), the overall response rate was 40%, with 27% achieving a very good partial response or better.[90][Level of evidence C3]
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In a prospective trial (BELLINI [NCT02755597]), 291 patients with relapsed or refractory myeloma were randomly assigned to receive venetoclax plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone.[91]
In a prospective trial (BELLINI [NCT02755597]), 291 patients with relapsed or refractory myeloma were randomly assigned to receive venetoclax plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone.[91]
With a median follow-up of 18.7 months, the median PFS was 22.4 months for patients on the venetoclax arm versus 11.5 months for patients on the placebo arm (HR, 0.63; 95% CI, 0.44–0.90; P = .01).
In a prospective trial (BELLINI [NCT02755597]), 291 patients with relapsed or refractory myeloma were randomly assigned to receive venetoclax plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone.[91]
OS favored the placebo arm because of treatment-related sepsis (HR, 2.03; 95% CI, 1.04–3.95; P = .034).[91][Level of evidence A1]
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In a prospective trial (BELLINI [NCT02755597]), 291 patients with relapsed or refractory myeloma were randomly assigned to receive venetoclax plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone.[91]
A prespecified analysis of 35 patients with t(11;14) translocation (20 patients who received venetoclax and 15 patients who received placebo) resulted in the median PFS not being reached for patients on the venetoclax arm versus 9.5 months for patients on the placebo arm (HR, 0.11; 95% CI, 0.02–0.56; P = .004).[91][Level of evidence B1]
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Preserved source evidence · Not medical advice