A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Summary

This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

Timeline

Start

2016-07-11

Primary completion

2021-03-15

Completion

2022-08-15

Outcome

Met primary endpoint

paper The primary endpoint was met with a significant improvement in independent review committee-assessed progression-free survival with venetoclax versus placebo plus bortezomib and dexamethasone. PMID 33129376 ↗

registry p =0.012; Hazard Ratio (HR) 0.656 (95% CI 0.471 to 0.913) NCT02755597 ↗

Publications

• Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Onishi M, Ku G, Pothacamury R, Jalaluddin M, Zeng J, Ross JA, Dobkowska E, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma (BELLINI): final overall survival results from a randomised, phase 3 study. Lancet Haematol. 2025 Aug;12(8):e574-e587. doi: 10.1016/S2352-3026(25)00139-5. Epub 2025 Jun 27.
• Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	800 mg	Oral
Background	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Background	Dexamethasone	Small molecule	20 mg	Oral

Indications