Multiple Myeloma Clinical Trial
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Summary
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:
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
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There are 32 Locations for this study
Birmingham Alabama, 35233, United States
Little Rock Arkansas, 72205, United States
Hollywood Florida, 33021, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46237, United States
Lexington Kentucky, 40536, United States
Lewiston Maine, 04240, United States
Baltimore Maryland, 21201, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75390, United States More Info
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98108, United States
Wauwatosa Wisconsin, 53226, United States
East Albury New South Wales, 2640, Australia
Waratah New South Wales, 2298, Australia
Bedford, Park South Australia, 5042, Australia
Hobart Tasmania, 7000, Australia
Szeged Csongrad, 6725, Hungary
Debrecen Hajdu-Bihar, 4032, Hungary
Budapest , 1085, Hungary
Budapest , 1097, Hungary
San Juan , 00918, Puerto Rico
San Juan , 00921, Puerto Rico
Badalona Barcelona, 08916, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
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