Clinical Trial: Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

Brief Summary:

The purposes of this study are:

• To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
• To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Mean Duration of Treatment With Vorinostat [ Time Frame: Day 1 to an event causing discontinuation from the study, assessed up to 29 months ]

Original Primary Outcome:

Current Secondary Outcome:

• Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug [ Time Frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months ]
  An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
• Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib [ Time Frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months ]
  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
• Clinical AE Summary [ Time Frame: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months) ]

  An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

  A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.

• Laboratory AE Summary [ Time Frame: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months ]

  An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

  A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.

  A lab (S)AE was any lab value considered clinically significant in the investigator's judgment.

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: May 25, 2005
Date Started: September 2005
Date Completion:
Last Updated: May 5, 2015
Last Verified: May 2015