Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma

Phase 1/2 Completed 117 enrolled AbbVie Genentech, Inc. · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma. The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

Timeline

Start: 2012-10-10
Primary completion: 2021-11-29
Completion: 2021-11-29

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Venetoclax	Small molecule	300 mg	Oral
Subject	Venetoclax	Small molecule	600 mg	Oral
Subject	Venetoclax	Small molecule	800 mg	Oral
Subject	Venetoclax	Small molecule	900 mg	Oral
Subject	Venetoclax	Small molecule	1200 mg	Oral

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications