Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (MM)
Trial Status: Active
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.
- Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to
- - Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
- Received prior treatment with at least 1, but no more than 3, prior lines 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.
- For Part 3, Cohort 7, participants must meet the above criteria and also be positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
- 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
- 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 subject'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
University of Alabama at Birmingham Cancer Center
Emory University Hospital / Winship Cancer Institute
University of Chicago Comprehensive Cancer Center
University of Kentucky / Markey Cancer Center
Contact: Gregory P. Monohan
Duke University Medical Center
University of Pennsylvania / Abramson Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase II
Trial Type Treatment
- Primary ID M15-538
- Secondary IDs NCI-2016-01672
- Clinicaltrials.gov ID NCT02899052