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

Running, not enrolling · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT02899052

Run by

AbbVie

People needed

120

Starts

2017-01-19

Expected to finish

2027-06-01

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham - Main /ID# 151405 — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences /ID# 151399 — Little Rock, Arkansas, United States
• Memorial Healthcare System /ID# 224862 — Hollywood, Florida, United States
• Winship Cancer Institute of Emory University /ID# 161710 — Atlanta, Georgia, United States
• The University of Chicago Medical Center /ID# 151395 — Chicago, Illinois, United States
• Indiana Blood & Marrow Transpl /ID# 218862 — Indianapolis, Indiana, United States
• Duplicate_University of Kentucky Chandler Medical Center /ID# 151407 — Lexington, Kentucky, United States
• Central Maine Medical Center /ID# 218856 — Lewiston, Maine, United States
• Duplicate_University of Maryland School of Medicine /ID# 159721 — Baltimore, Maryland, United States
• Oncology Hematology Associates (OHA) - Springfield /ID# 218855 — Springfield, Missouri, United States
• Washington University-School of Medicine /ID# 222651 — St Louis, Missouri, United States
• Duke Cancer Center /ID# 162062 — Durham, North Carolina, United States
• University of Pennsylvania /ID# 151768 — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center /ID# 218336 — Dallas, Texas, United States
• Baylor Scott & White Medical Center- Temple /ID# 218252 — Temple, Texas, United States
• University of Utah /ID# 151397 — Salt Lake City, Utah, United States
• Duplicate_VA Puget Sound Healthcare Syst /ID# 155369 — Seattle, Washington, United States
• Aurora Health Care, Aurora Cancer Center /ID# 209612 — Wauwatosa, Wisconsin, United States
• Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200 — East Albury, New South Wales, Australia
• Calvary Mater Newcastle /ID# 218739 — Waratah, New South Wales, Australia
• Flinders Medical Centre /ID# 221345 — Bedford Park, South Australia, Australia
• Royal Hobart Hospital /ID# 217546 — Hobart, Tasmania, Australia
• Debreceni Egyetem-Klinikai Kozpont /ID# 217624 — Debrecen, Hajdú-Bihar, Hungary
• Semmelweis Egyetem /ID# 217626 — Budapest, Hungary
• Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625 — Budapest, Hungary

Full record on ClinicalTrials.gov

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