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
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.
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