Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

  • Interventional
  • Recruiting
  • NCT02899052
Eligibility Details Visit

A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT02899052


Lead SponsorAbbVie

Lead PhysicianAndrzej Jakubowiak


18 Years and up