Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
NCT ID: NCT02899052
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2017-01-19
2027-06-30
Brief Summary
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Part 4 of this study is currently enrolling.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax + Carfilzomib + Dexamethasone
Part 1: Evaluate the safety and pharmacokinetic profiles while providing information to determine the appropriate doses of venetoclax and carfilzomib (VenKd) to be used in the VenKd combination in approximately 18 participants. The dose levels are Venetoclax 400 mg or 800 mg; Carfilzomib 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; Dexamethasone 40 mg
Part 2: Further evaluate the safety and efficacy profile of the VenKd combination selected after completion of Part 1 in approximately 22 additional participants. Participants may discontinue Kd but may continue receiving venetoclax once daily (QD) as monotherapy.
Part 3: Further evaluation of the efficacy of the VenKd combination after completion of Part 1 and Part 2 in 7 additional participants.
Part 4, An additional 65 participants t(11;14) positive will receive varying doses of the VenKd combination or carfilzomib and dexamethasone
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
* Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
* Received prior treatment with at least 1 prior line of therapy for MM.
* Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
* Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.
Exclusion Criteria
* Non-secretory or oligo-secretory MM
* Active plasma cell leukemia.
* Waldenström's macroglobulinemia.
* Primary amyloidosis.
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
* Active hepatitis B or C infection based on screening blood testing.
* Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Significant cardiovascular disease.
* Major surgery within 4 weeks prior to first dose.
* Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose.
* Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
* Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose.
* Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study.
18 Years
ALL
No
Sponsors
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Genentech, Inc; Onyx Therapeutics, Inc.
UNKNOWN
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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References
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Badawi MA, Engelhardt B, Dobkowska E, Deng R, Kaufman JL, Menon R, Salem AH. Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients. Invest New Drugs. 2024 Dec;42(6):635-643. doi: 10.1007/s10637-024-01471-x. Epub 2024 Oct 10.
Costa LJ, Davies FE, Monohan GP, Kovacsovics T, Burwick N, Jakubowiak A, Kaufman JL, Hong WJ, Dail M, Salem AH, Yang X, Masud AA, Munasinghe W, Ross JA, Bueno OF, Kumar SK, Stadtmauer EA. Phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Blood Adv. 2021 Oct 12;5(19):3748-3759. doi: 10.1182/bloodadvances.2020004146.
Other Identifiers
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2019-004340-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-538
Identifier Type: -
Identifier Source: org_study_id
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