Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00858234
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.
  • Bortezomib — DRUG
    Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.

Study Details

The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.

Key Dates

Start date
Feb 13, 2009
Status verified
Apr 2021
Primary completion
Jun 11, 2010
Completion
Apr 19, 2012

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat + Bortezomib
    Participants undergo up to 3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg once daily \[QD\] on Days 1 through 14) + bortezomib (1.3 mg/m\^2 intravenous \[IV\] on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1 [ Time Frame: Up to 21 days ]

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