Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Phase 2 – studying effectiveness and dosage
Conditions:
Multiple Myeloma
Sponsor: AbbVie
trial.available_in:
БГ
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.
Who can participate
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
5
Australia (1)
Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200
East Albury , New South Wales
Hungary (1)
Debreceni Egyetem-Klinikai Kozpont /ID# 217624
Debrecen , Hajdú-Bihar
Puerto Rico (1)
Auxilio Mutuo Cancer Center /ID# 157853
San Juan
Spain (1)
Hospital Universitario Germans Trias i Pujol /ID# 218006
Badalona , Barcelona
United States (1)
University of Alabama at Birmingham - Main /ID# 151405