Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Purpose
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.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2. - 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
- Has a pre-existing condition that is contraindicated including. - 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. - History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 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 |
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Recruiting Locations
University of Alabama at Birmingham - Main /ID# 151405
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Emory University, Winship Cancer Institute /ID# 161710
Atlanta, Georgia 30322
Atlanta, Georgia 30322
The University of Chicago Medical Center /ID# 151395
Chicago, Illinois 60637-1443
Chicago, Illinois 60637-1443
Indiana Blood & Marrow Transpl /ID# 218862
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Washington University-School of Medicine /ID# 222651
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Oncology Hematology Associates (OHA) - Springfield /ID# 218855
Springfield, Missouri 65807-5287
Springfield, Missouri 65807-5287
Duke Cancer Center /ID# 162062
Durham, North Carolina 27710-3000
Durham, North Carolina 27710-3000
University of Pennsylvania /ID# 151768
Philadelphia, Pennsylvania 19104-5502
Philadelphia, Pennsylvania 19104-5502
University of Texas Southwestern Medical Center /ID# 218336
Dallas, Texas 75390-7208
Dallas, Texas 75390-7208
Contact:
Site Coordinator
844-663-3742
Site Coordinator
844-663-3742
University of Utah /ID# 151397
Salt Lake City, Utah 84112-5500
Salt Lake City, Utah 84112-5500
Aurora Health Care, Aurora Cancer Center /ID# 209612
Wauwatosa, Wisconsin 53226-3436
Wauwatosa, Wisconsin 53226-3436
Auxilio Mutuo Cancer Center /ID# 157853
San Juan, Puerto Rico 00918
San Juan, Puerto Rico 00918
More Details
- NCT ID
- NCT02899052
- Status
- Recruiting
- Sponsor
- AbbVie