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Active (not recruiting) Phase 2 NCT02899052

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
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
19.01.2017
Completion date
01.06.2027
Registry ID
NCT02899052
Source
anzctr
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