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

  • Interventional
  • Recruiting
  • NCT02899052
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

         - 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.

        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

At a Glance

National Government IDNCT02899052

IRB#IRB16-0887

Lead SponsorAbbVie

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting