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Completed

NCT Number: NCT00858234

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorinostat

Drug

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

Other names: MK-0683, ZOLINZA™

bortezomib

Drug

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

Other names: VELCADE®

Primary outcomes

  1. Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1

    Time frame: Up to 21 days

    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).

Other outcomes

  1. Number of Participants With an Adverse Event (AE)

    Time frame: Up to 346 days (up to 30 days after the final dose of study treatment)

    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).

  2. 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

    Time frame: 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

    The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Mar 9, 2009
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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