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

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.

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

Venetoclax : National Cancer Institute

Venetoclax : MedlinePlus Drug Information

Drug: Dexamethasone

Drug: ABT-199

---

Drug: ABT-199

ABT-0199

ABT-199

ABT199

GDC-0199

RG7601

Venclexta

Venclyxto

Venetoclax

VENETOCLAX

Bcl-2 inhibitor GDC-0199

Venclexta

---

Blood; 2017 Nov

Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma

Venetoclax is a selective, orally bioavailable BCL-2 inhibitor that induces cell death in multiple myeloma (MM) cells, particularly in those harboring t(11;14), which express high levels of BCL-2 relative to BCL-XL and MCL-1. In this phase 1 study, patients with relapsed/refractory MM received venetoclax monotherapy....

Click here for details

---

Br J Haematol; 2020

Real-world data on safety and efficacy of venetoclax-based regimens in relapsed/refractory t(11;14) multiple myeloma

The treatment for relapsed/refractory multiple myeloma (RRMM) continues to be challenging despite recent therapeutic advancements. Venetoclax, an inhibitor of the anti-apoptotic protein BCL-2, is a promising agent, especially in patients harbouring t(11;14). Our objective was to review our experience with venetoclax-based regimens at our institution. All ten RRMM patients treated with venetoclax were included and had a median of six prior lines of therapy. The overall response rate was 78% and one patient with cardiac amyloidosis and MM achieved a cardiac organ response. Haematologic toxicities requiring red blood cell and platelet transfusion and non-haematologic toxicities, most commonly gastrointestinal upset, were observed.

https://pubmed.ncbi.nlm.nih.gov/32012228/

---

Am J Hematol;. 2021

Targeting BCL-2 with venetoclax and dexamethasone in patients with relapsed/refractory t(11;14) multiple myeloma

Venetoclax (Ven) is a selective small-molecule inhibitor of BCL-2 that exhibits antitumoral activity against MM cells with t(11;14) translocation. We evaluated the safety and efficacy of Ven and dexamethasone (VenDex) combination in patients with t(11;14) positive relapsed/refractory (R/R) multiple myeloma (MM).

https://pubmed.ncbi.nlm.nih.gov/33368455/

---

Locations

United States, Arizona

United States, Arkansas

United States, Connecticut

United States, Georgia

United States, Illinois

United States, Louisiana

United States, Massachusetts

United States, Michigan

United States, Minnesota

United States, Mississippi

United States, Missouri

United States, Nebraska

United States, New Jersey

United States, North Carolina

United States, Ohio

United States, South Dakota

United States, Texas

United States, Washington

United States, Wisconsin

Belgium

France

Norway