Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00111813
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
  • bortezomib — DRUG
    Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.

Study Details

The purposes of this study are: * To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma * To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Key Dates

Start date
Sep 30, 2005
Status verified
May 2015
Primary completion
Dec 31, 2009
Completion
May 31, 2011

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: vorinostat 200 mg + bortezomib 0.7 mg/m^2
    Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
  • Experimental: vorinostat 200 mg + bortezomib 0.9 mg/m^2
    Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
  • Experimental: vorinostat 300 mg + bortezomib 1.3 mg/m^2
    Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
  • Experimental: vorinostat 400 mg + bortezomib 0.9 mg/m^2
    Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
  • Experimental: vorinostat 400 mg + bortezomib 1.1 mg/m^2
    Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
  • Experimental: vorinostat 400 mg + bortezomib 1.3 mg/m^2
    Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Primary Outcome Measure

Mean Duration of Treatment With Vorinostat [ Time Frame: Day 1 to an event causing discontinuation from the study, assessed up to 29 months ]

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