Phase 2 Clinical Trial Evaluating the Safety, Tolerability, and Effectiveness of Venetoclax combined with Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma

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Overview

The goal of this clinical trial is to determine the safety, effectiveness, and tolerability of venetoclax in combination with carfilzomib and dexamethasone. This combination is being evaluated in participants with relapsed/refractory multiple myeloma. 

SparkCures ID 839
Trial Phase Phase 2
Enrollment 120 Patients
Treatments
Tags
Trial Sponsors
  • AbbVie
Trial Collaborators
  • Amgen
  • Genentech
NCT Identifier

NCT02899052

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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
  • 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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