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

NCT ID: NCT00858234

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-13
• Study Completion Date: 2012-04-19

Brief Summary

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Vorinostat

Intervention Type: DRUG

Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.

Bortezomib

Intervention Type: DRUG

Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.

Interventions

Vorinostat

Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.

Intervention Type: DRUG

Bortezomib

Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.

Intervention Type: DRUG

Other Intervention Names

MK-0683; ZOLINZA™; VELCADE®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Ogawa Y, Ogura M, Tobinai K, Ando K, Suzuki T, Watanabe T, Ohmachi K, Uchida T, Hanson ME, Tanaka Y, Koh Y, Shimamoto T, Hotta T. A phase I study of vorinostat combined with bortezomib in Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2016 Jan;103(1):25-33. doi: 10.1007/s12185-015-1897-7. Epub 2015 Nov 30.

Reference Type: RESULT

PMID: 26619834 (View on PubMed)

Other Identifiers

MK-0683-098

Identifier Type: OTHER

Identifier Source: secondary_id

0683-098

Identifier Type: -

Identifier Source: org_study_id