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



Status:Suspended
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 19, 2017
End Date:February 19, 2022

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A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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.


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.

- Received prior treatment with at least 1, but no more than 3, prior lines 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.

- For Part 3, Cohort 7, participants must meet the above criteria and also be positive
for translocation t(11;14) as determined by an analytically validated Fluorescent In
Situ Hybridization (FISH) assay per central laboratory testing.

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

- 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 subject'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
We found this trial at
16
sites
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Atlanta, Georgia 30322
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Atlanta, GA
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Baltimore, Maryland 21201
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Baltimore, MD
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Birmingham, Alabama 35233
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Birmingham, AL
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Chicago, Illinois 60637
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Chicago, IL
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2301 Erwin Road
Durham, North Carolina 27710
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Durham, NC
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Fullerton, CA
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Greenbrae, California 94904
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Greenbrae, CA
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La Crosse, Wisconsin 54601
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La Crosse, WI
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Lexington, KY
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4301 West Markham Street
Little Rock, Arkansas 72205
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Little Rock, AR
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Salt Lake City, Utah 84112
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Salt Lake City, UT
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San Juan,
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Seattle, Washington 98108
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Seattle, WA
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Wauwatosa, WI
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West Hollywood, CA
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