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

Last updated: August 1, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lymphoproliferative Disorders

Cancer

Leukemia

Treatment

Dexamethasone

Venetoclax

Carfilzomib

Clinical Study ID

NCT02899052
M15-538
2019-004340-30
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Collaborative Oncology Group (ECOG) performance score of less than or equalto 2.

  • Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen oris refractory to the most recent line of therapy.

  • Positive for translocation t(11;14) as determined by an analytically validatedFluorescent 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 kidneyfunction laboratory values within 2 weeks prior to first dose of study drug.

Exclusion

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, monoclonalprotein, 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 within14days prior to first dose.

  • Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior tofirst dose.

  • Uncontrolled diabetes or uncontrolled hypertension within 14 days prior tofirst dose.

  • Any other medical condition that, in the opinion of the Investigator, wouldadversely 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 definedinclusion/exclusion criteria could apply

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
January 19, 2017
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200

    East Albury, New South Wales 2640
    Australia

    Site Not Available

  • Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 222200

    East Albury, New South Wales 2640
    Australia

    Completed

  • Calvary Mater Newcastle /ID# 218739

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Flinders Medical Centre /ID# 221345

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Flinders Medical Centre /ID# 221345

    Bedford, Park, South Australia 5042
    Australia

    Site Not Available

  • Royal Hobart Hospital /ID# 217546

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 217625

    Budapest IX, Budapest 1097
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 219172

    Szeged, Csongrad 6725
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont /ID# 217624

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

  • Debreceni Egyetem-Klinikai Kozpont /ID# 217624

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Site Not Available

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625

    Budapest, 1097
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 217626

    Budapest, 1085
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 217626

    Budapest VIII, 1088
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem /ID# 219172

    Szeged, 6720
    Hungary

    Site Not Available

  • Auxilio Mutuo Cancer Center /ID# 157853

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • VA Caribbean Healthcare System /ID# 157854

    San Juan, 00921-3201
    Puerto Rico

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol /ID# 218006

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona /ID# 218007

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon /ID# 218005

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal /ID# 220925

    Madrid, 28034
    Spain

    Site Not Available

  • University of Alabama at Birmingham - Main /ID# 151405

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences /ID# 151399

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • St Jude Medical Center / St Joseph Health /ID# 210183

    Fullerton, California 92835-3820
    United States

    Site Not Available

  • Marin Cancer Care /ID# 210408

    Greenbrae, California 94904
    United States

    Site Not Available

  • Pacific Cancer Care /ID# 217689

    Salinas, California 93901
    United States

    Site Not Available

  • Cedars-Sinai Medical Center - West Hollywood /ID# 210819

    West Hollywood, California 90048
    United States

    Site Not Available

  • Memorial Healthcare System /ID# 224862

    Hollywood, Florida 33021-3513
    United States

    Site Not Available

  • Emory University, Winship Cancer Institute /ID# 161710

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University /ID# 161710

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • The University of Chicago Medical Center /ID# 151395

    Chicago, Illinois 60637-1443
    United States

    Site Not Available

  • Indiana Blood & Marrow Transpl /ID# 218862

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Univ Kansas Med Ctr /ID# 210203

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Duplicate_University of Kentucky Chandler Medical Center /ID# 151407

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center /ID# 151407

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Central Maine Medical Center /ID# 218856

    Lewiston, Maine 04240
    United States

    Site Not Available

  • Duplicate_University of Maryland School of Medicine /ID# 159721

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • Univ Maryland School Medicine /ID# 159721

    Baltimore, Maryland 21201-1544
    United States

    Completed

  • University of Maryland School of Medicine /ID# 159721

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • Cape Cod Hospital /ID# 151765

    Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 222651

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Oncology Hematology Associates (OHA) - Springfield /ID# 218855

    Springfield, Missouri 65807-5287
    United States

    Site Not Available

  • Carolinas Medical Center /ID# 161711

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke Cancer Center /ID# 162062

    Durham, North Carolina 27710-3000
    United States

    Site Not Available

  • University of Pennsylvania /ID# 151768

    Philadelphia, Pennsylvania 19104-5502
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-0011
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center /ID# 218336

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Baylor Scott & White Medical Center- Temple /ID# 218252

    Temple, Texas 76508-0001
    United States

    Site Not Available

  • University of Utah /ID# 151397

    Salt Lake City, Utah 84112-5500
    United States

    Site Not Available

  • Duplicate_VA Puget Sound Healthcare Syst /ID# 155369

    Seattle, Washington 98108
    United States

    Site Not Available

  • Gundersen Health System /ID# 210807

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • Univ of Wisconsin Hosp/Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Aurora Health Care, Aurora Cancer Center /ID# 209612

    Wauwatosa, Wisconsin 53226-3436
    United States

    Site Not Available

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