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

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02899052
Protocol IDs
M15-538 (primary)
NCI-2016-01672
Study Sponsor
Abbvie

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

  1. 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.
  3. Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
  4. Received prior treatment with at least 1 prior line of therapy for MM.
  5. Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
  6. Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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