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 |
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.
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
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4301 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
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