120
Participants
Start Date
January 19, 2017
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
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."
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.
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.
Semmelweis Egyetem /ID# 217626, Budapest
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625, Budapest
Calvary Mater Newcastle /ID# 218739, Waratah
Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200, East Albury
Debreceni Egyetem-Klinikai Kozpont /ID# 217624, Debrecen
Flinders Medical Centre /ID# 221345, Bedford Park
Szegedi Tudományegyetem /ID# 219172, Szeged
Royal Hobart Hospital /ID# 217546, Hobart
Hospital General Universitario Gregorio Maranon /ID# 218005, Madrid
Hospital Universitario Ramon y Cajal /ID# 220925, Madrid
Winship Cancer Institute of Emory University /ID# 161710, Atlanta
University of Alabama at Birmingham - Main /ID# 151405, Birmingham
Duplicate_University of Kentucky Chandler Medical Center /ID# 151407, Lexington
Indiana Blood & Marrow Transpl /ID# 218862, Indianapolis
Washington University-School of Medicine /ID# 222651, St Louis
University of Arkansas for Medical Sciences /ID# 151399, Little Rock
Duplicate_VA Puget Sound Healthcare Syst /ID# 155369, Seattle
Memorial Healthcare System /ID# 224862, Hollywood
The University of Chicago Medical Center /ID# 151395, Chicago
Central Maine Medical Center /ID# 218856, Lewiston
Duplicate_University of Maryland School of Medicine /ID# 159721, Baltimore
Oncology Hematology Associates (OHA) - Springfield /ID# 218855, Springfield
Duke Cancer Center /ID# 162062, Durham
University of Pennsylvania /ID# 151768, Philadelphia
University of Texas Southwestern Medical Center /ID# 218336, Dallas
Baylor Scott & White Medical Center- Temple /ID# 218252, Temple
University of Utah /ID# 151397, Salt Lake City
Aurora Health Care, Aurora Cancer Center /ID# 209612, Wauwatosa
Auxilio Mutuo Cancer Center /ID# 157853, San Juan
VA Caribbean Healthcare System /ID# 157854, San Juan
Hospital Universitario Germans Trias i Pujol /ID# 218006, Badalona
Hospital Clinic de Barcelona /ID# 218007, Barcelona
Lead Sponsor
Genentech, Inc; Onyx Therapeutics, Inc.
UNKNOWN
AbbVie
INDUSTRY