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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Vorinostat; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858234

MK-0683-098 (Other Identifier)

0683-098

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• is ≥20 years of age.
• has an established diagnosis of MM based on the myeloma diagnostic criteria
• has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen
• has adequate organ function

Exclusion criteria

• has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study
• has known hypersensitivity to any components of vorinostat or bortezomib
• has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive
• has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Vorinostat + Bortezomib

Experimental group

Description:

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).

Treatment:

Drug: Bortezomib

Drug: Vorinostat