A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
M15-654
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Dexamethasone
  • Daratumumab
  • Venetoclax
  • Bortezomib
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

    Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

    Study Locations

    Location
    Status
    Location
    Univ of Colorado Cancer Center /ID# 167331
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Moffitt Cancer Center /ID# 169614
    Tampa, Florida, United States, 33612-9416
    Status
    Not applicable
    Location
    Winship Cancer Institute of Emory University /ID# 165427
    Atlanta, Georgia, United States, 30322
    Status
    Not applicable
    Location
    The University of Chicago Medical Center /ID# 165429
    Chicago, Illinois, United States, 60637-1443
    Status
    Not applicable
    Location
    Beth Israel Deaconess Medical Center /ID# 210904
    Boston, Massachusetts, United States, 02215-5400
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute /ID# 166886
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
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