A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Phase 3 Active not recruiting 265 enrolled AbbVie Roche-Genentech · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

Timeline

Start: 2018-10-22
Primary completion: 2026-08
Completion: 2027-11

Outcome

Missed primary endpoint

paper The primary end point of PFS was not met. PMID 41370738 ↗

Publications

Popat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, Kapoor P, Katodritou E, Kortum KM, Ling S, Nagarajan C, Suzuki K, Qiu L, Onishi M, Ku G, Dail M, Mukherjee N, Ross JA, Badawi MA, Fusco MJ, Dobkowska E, Arriola E, Bueno OF, Bahlis NJ, Iida S, Moreau P, Valent J, Mateos MV. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2026 Jan 20;44(3):164-175. doi: 10.1200/JCO-25-00924. Epub 2025 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pomalidomide	Other / unclassified	—	Oral
Subject	Venetoclax	Small molecule	—	Oral
Background	Dexamethasone	Small molecule	—	Oral