A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2 Terminated 8 enrolled AbbVie Celgene Corporation · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.

Timeline

Start: 2018-10-18
Primary completion: 2020-06-18
Completion: 2020-06-18

Outcome

Outcome not reported

Stopped: “Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.”

Publications

Gasparetto C, Bowles KM, Abdallah AO, Morris L, Mander G, Coppola S, Wang J, Ross JA, Bueno OF, Arriola E, Mateos MV. A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):775-784. doi: 10.1016/j.clml.2021.07.029. Epub 2021 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	400 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Pomalidomide	Other / unclassified	4 mg	Oral