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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
4301 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials