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

Sponsor: AbbVie

Sponsor score: 60

ClinicalTrials ID:NCT02899052

This Phase 2 study evaluates venetoclax with carfilzomib-dexamethasone in relapsed/refractory MM patients. Eligible participants have ECOG ≤2, t(11;14) positivity, and prior therapy. Carfilzomib is given intravenously, venetoclax orally, and dexamethasone orally, with varying doses across cycles. Participants must meet specific lab criteria before starting treatment.

Patient Parameters

Program Overview

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

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham - Main /ID# 15140535233BirminghamAlabama
University of Arkansas for Medical Sciences /ID# 15139972205Little RockArkansas
Memorial Healthcare System /ID# 22486233021-3513HollywoodFlorida
Winship Cancer Institute of Emory University /ID# 16171030322AtlantaGeorgia
The University of Chicago Medical Center /ID# 15139560637-1443ChicagoIllinois
Indiana Blood & Marrow Transpl /ID# 21886246237IndianapolisIndiana
Duplicate_University of Kentucky Chandler Medical Center /ID# 15140740536LexingtonKentucky
Central Maine Medical Center /ID# 21885604240LewistonMaine
Duplicate_University of Maryland School of Medicine /ID# 15972121201-1544BaltimoreMaryland
Oncology Hematology Associates (OHA) - Springfield /ID# 21885565807-5287SpringfieldMissouri

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