Trial Information
Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
Inclusion Criteria:
- Adults with refractory or relapsed multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to
determine participant's ability to perform daily activities)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria:
- Participants who plan to have a bone marrow transplant within 4 weeks of start of
treatment
- Participants with prior treatment with other investigational agents with a similar
anti-tumor mechanism
- Participants with other active/uncontrolled clinically significant illness
- Pregnant or nursing female participants
- Participants who received bortezomib within 3 months of start of this trial
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean Duration of Treatment With Vorinostat
Outcome Description:
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.
Progressive disease was defined as:
>25% increase in the level of serum monoclonal paraprotein.
25% increase in 24-hour urinary light chain excretion.
>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy.
Development of new bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia.
Intolerable toxicity was based on the clinical judgment of the investigator.
Outcome Time Frame:
Day 1 to an event causing discontinuation from the study, assessed up to 29 months
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
MK-0683-015
NCT ID:
NCT00111813
Start Date:
September 2005
Completion Date:
May 2011
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
