Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Sponsor: AbbVie
ClinicalTrials ID:NCT02899052
This Phase 2 study evaluates venetoclax with carfilzomib-dexamethasone in relapsed/refractory MM patients. Eligible participants have ECOG ≤2, t(11;14) positivity, and prior therapy. Carfilzomib is given intravenously, venetoclax orally, and dexamethasone orally, with varying doses across cycles. Participants must meet specific lab criteria before starting treatment.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
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
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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.
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 151405 | 35233 | Birmingham | Alabama |
| University of Arkansas for Medical Sciences /ID# 151399 | 72205 | Little Rock | Arkansas |
| Memorial Healthcare System /ID# 224862 | 33021-3513 | Hollywood | Florida |
| Winship Cancer Institute of Emory University /ID# 161710 | 30322 | Atlanta | Georgia |
| The University of Chicago Medical Center /ID# 151395 | 60637-1443 | Chicago | Illinois |
| Indiana Blood & Marrow Transpl /ID# 218862 | 46237 | Indianapolis | Indiana |
| Duplicate_University of Kentucky Chandler Medical Center /ID# 151407 | 40536 | Lexington | Kentucky |
| Central Maine Medical Center /ID# 218856 | 04240 | Lewiston | Maine |
| Duplicate_University of Maryland School of Medicine /ID# 159721 | 21201-1544 | Baltimore | Maryland |
| Oncology Hematology Associates (OHA) - Springfield /ID# 218855 | 65807-5287 | Springfield | Missouri |
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