Multiple Myeloma Clinical Trial

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

Summary

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT02899052

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 32 Locations for this study

See Locations Near You

University of Alabama at Birmingham - Main /ID# 151405
Birmingham Alabama, 35233, United States
University of Arkansas for Medical Sciences /ID# 151399
Little Rock Arkansas, 72205, United States
Memorial Healthcare System /ID# 224862
Hollywood Florida, 33021, United States
Emory University, Winship Cancer Institute /ID# 161710
Atlanta Georgia, 30322, United States
The University of Chicago Medical Center /ID# 151395
Chicago Illinois, 60637, United States
Indiana Blood & Marrow Transpl /ID# 218862
Indianapolis Indiana, 46237, United States
University of Kentucky Chandler Medical Center /ID# 151407
Lexington Kentucky, 40536, United States
Central Maine Medical Center /ID# 218856
Lewiston Maine, 04240, United States
University of Maryland School of Medicine /ID# 159721
Baltimore Maryland, 21201, United States
Washington University-School of Medicine /ID# 222651
Saint Louis Missouri, 63110, United States
Oncology Hematology Associates (OHA) - Springfield /ID# 218855
Springfield Missouri, 65807, United States
Duke Cancer Center /ID# 162062
Durham North Carolina, 27710, United States
University of Pennsylvania /ID# 151768
Philadelphia Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center /ID# 218336
Dallas Texas, 75390, United States
Baylor Scott & White Medical Center- Temple /ID# 218252
Temple Texas, 76508, United States
University of Utah /ID# 151397
Salt Lake City Utah, 84112, United States
Duplicate_VA Puget Sound Healthcare Syst /ID# 155369
Seattle Washington, 98108, United States
Aurora Health Care, Aurora Cancer Center /ID# 209612
Wauwatosa Wisconsin, 53226, United States
Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200
East Albury New South Wales, 2640, Australia
Calvary Mater Newcastle /ID# 218739
Waratah New South Wales, 2298, Australia
Flinders Medical Centre /ID# 221345
Bedford, Park South Australia, 5042, Australia
Royal Hobart Hospital /ID# 217546
Hobart Tasmania, 7000, Australia
Debreceni Egyetem-Klinikai Kozpont /ID# 217624
Debrecen Hajdu-Bihar, 4032, Hungary
Semmelweis Egyetem /ID# 217626
Budapest , 1085, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625
Budapest , 1097, Hungary
Szegedi Tudományegyetem /ID# 219172
Szeged , 6720, Hungary
Auxilio Mutuo Cancer Center /ID# 157853
San Juan , 00918, Puerto Rico
VA Caribbean Healthcare System /ID# 157854
San Juan , 00921, Puerto Rico
Hospital Universitario Germans Trias i Pujol /ID# 218006
Badalona Barcelona, 08916, Spain
Hospital Clinic de Barcelona /ID# 218007
Barcelona , 08036, Spain
Hospital General Universitario Gregorio Maranon /ID# 218005
Madrid , 28007, Spain
Hospital Universitario Ramon y Cajal /ID# 220925
Madrid , 28034, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT02899052

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

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