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NCT01794520: Phase 1/2: Study Evaluating ABT-199 in Participants With Relapsed or Refractory MM

Updated: Jun 15, 2022


NCT01794520: Phase 1/2: Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma


abt199

The phase 1 primary objectives of this study are 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 will also assess 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 is 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.


Sponsor

AbbVie


Collaborator

Genentech, Inc.


Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT01794520

Official Title: A Phase I/II Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

First Posted : February 20, 2013


Click here for details on Clinical Trials.gov

 

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information