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

Multiple Myeloma Clinical Trial

Official title:

A Multicenter, Open-Label, Phase I Study of MK-0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858234
• Other study ID #: 0683-098
• Secondary ID: MK-0683-098
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2009
• Est. completion date: April 19, 2012

Study information

• Verified date: April 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 19, 2012
• Est. primary completion date: June 11, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With an Adverse Event (AE)	The number of participants with =1 AE is reported. An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product(s), whether or not considered related to the use of the product(s).	Up to 346 days (up to 30 days after the final dose of study treatment)
Other	Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11	The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.	Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11
Primary	Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1	The number of participants with =1 DLT during Cycle 1 is reported. A DLT is defined as an event considered by the investigator to be related to study treatment, and either: 1) a Grade 3 or 4 non-hematologic event (except for manageable toxicity by supportive care or non-prohibited therapies, or a transient increase in alanine aminotransferase [ALT]/aspartate aminotransferase [AST]); or 2) a Grade 4 hematologic toxicity except neutropenia or hemoglobin decreased (neutropenia was a DLT if it was Grade 3-4 with fever =38.5°C; Grade 3-4 with an infection requiring antibiotic/antifungal therapy; or Grade 4 and lasting =5 days).	Up to 21 days