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ACTIVE NOT RECRUITING
NCT02899052
PHASE2

Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy. Part 4 of this study is currently enrolling.

Official title: A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2017-01-19

Completion Date

2027-06

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

DRUG

Carfilzomib

Carfilzomib lyophilized administered intravenously as a 10 to 30 minute infusion in Cycles 1 and beyond within 30 minutes to 4 hours after dexamethasone dosing. Dose level 1 (K1) Cycle 1: 20 mg/m2 on Days 1 and 2, 27 mg/m2 on Days 8, 9, 15, and 16; Cycles 2 - 12: 27 mg/m2 on Days 1, 2, 8, 9, 15, and 16; Cycles 13 - 18: 27 mg/m2 on Days 1, 2, 15, and 16; Cycles 19 and beyond, for participants that have not previously transitioned to monotherapy: 27 mg/m2 on Days 1, 2, 15, and 16. Dose Level K2: Cycle 1: 20 mg/m2 on Day 1; 70 mg/m2 on Days 8 and 15 Cycles 2 - onward: 70 mg/m2 on Days 1, 8, and 15. Dose Level K3: Cycle 1: 20 mg/m2 on Days 1 and 2; 56 mg/m2 on Days 8, 9, 15, and 16. Cycles 2 - onward: 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16.

DRUG

Venetoclax

Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.

DRUG

Dexamethasone

Dexamethasone tablet administered orally during Cycles 1 - onward. Dexamethasone dose level 1 (Dex1) 40 mg once weekly, Dex2 40 mg once weekly, Dex3 20 mg twice weekly.

Locations (32)

University of Alabama at Birmingham - Main /ID# 151405

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences /ID# 151399

Little Rock, Arkansas, United States

Memorial Healthcare System /ID# 224862

Hollywood, Florida, United States

Winship Cancer Institute of Emory University /ID# 161710

Atlanta, Georgia, United States

The University of Chicago Medical Center /ID# 151395

Chicago, Illinois, United States

Indiana Blood & Marrow Transpl /ID# 218862

Indianapolis, Indiana, United States

Duplicate_University of Kentucky Chandler Medical Center /ID# 151407

Lexington, Kentucky, United States

Central Maine Medical Center /ID# 218856

Lewiston, Maine, United States

Duplicate_University of Maryland School of Medicine /ID# 159721

Baltimore, Maryland, United States

Oncology Hematology Associates (OHA) - Springfield /ID# 218855

Springfield, Missouri, United States

Washington University-School of Medicine /ID# 222651

St Louis, Missouri, United States

Duke Cancer Center /ID# 162062

Durham, North Carolina, United States

University of Pennsylvania /ID# 151768

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center /ID# 218336

Dallas, Texas, United States

Baylor Scott & White Medical Center- Temple /ID# 218252

Temple, Texas, United States

University of Utah /ID# 151397

Salt Lake City, Utah, United States

Duplicate_VA Puget Sound Healthcare Syst /ID# 155369

Seattle, Washington, United States

Aurora Health Care, Aurora Cancer Center /ID# 209612

Wauwatosa, Wisconsin, United States

Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200

East Albury, New South Wales, Australia

Calvary Mater Newcastle /ID# 218739

Waratah, New South Wales, Australia

Flinders Medical Centre /ID# 221345

Bedford Park, South Australia, Australia

Royal Hobart Hospital /ID# 217546

Hobart, Tasmania, Australia

Debreceni Egyetem-Klinikai Kozpont /ID# 217624

Debrecen, Hajdú-Bihar, Hungary

Semmelweis Egyetem /ID# 217626

Budapest, Hungary

Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625

Budapest, Hungary

Szegedi Tudományegyetem /ID# 219172

Szeged, Hungary

Auxilio Mutuo Cancer Center /ID# 157853

San Juan, Puerto Rico

VA Caribbean Healthcare System /ID# 157854

San Juan, Puerto Rico

Hospital Universitario Germans Trias i Pujol /ID# 218006

Badalona, Barcelona, Spain

Hospital Clinic de Barcelona /ID# 218007

Barcelona, Spain

Hospital General Universitario Gregorio Maranon /ID# 218005

Madrid, Spain

Hospital Universitario Ramon y Cajal /ID# 220925

Madrid, Spain