Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Evaluation will occur in four parts, with Part 1 being used to determine the appropriate doses of venetoclax and carfilzomib to use in later parts of the trial. Until appropriate doses have been confirmed, eligible participants will receive Venetoclax at a dose of 400 mg or 800 mg; Carfilzomib at a dose of 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; and Dexamethasone at a 40 mg dose. Parts 2-4 will further evaluate the safety and efficacy of the treatment combination.
Conditions
This trial is treating people with multiple myeloma
Eligibility
Inclusion
- 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AbbVie
Scientific Title
A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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