An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK0683) or Placebo in Combination With Bortezomib in Patients With Multiple Myeloma
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK0683) or Placebo in Combination With Bortezomib in Patients With Multiple Myeloma
Inclusion Criteria
Inclusion criteria
- Participant has an established diagnosis of multiple myeloma based on the myeloma
diagnostic criteria.
- Participant has received at least 1 but not more than 3 prior anti-myeloma regimens
and has progressive disease after the most recent treatment regimen.
- Participant must have adequate organ function.
Exclusion criteria:
- Participant has had a prior allogeneic bone marrow transplant or plans to undergo any
type of bone marrow transplantation within 4 weeks of the initiation of study
therapy.
- Participant has known hypersensitivity to any components of bortezomib or vorinostat.
- Participant has active Hepatitis B or C, plasma cell leukemia, or is human
immunodeficiency virus (HIV) positive.
- Participant has had prior treatment with vorinostat or histone deacetylase (HDAC)
inhibitors.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Duration of progression-free survival (PFS) in participants treated with vorinostat + bortezomib versus placebo + bortezomib
Outcome Time Frame:
From randomization to event of disease progression or death
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MK-0683-088
NCT ID:
NCT00773747
Start Date:
December 2008
Completion Date:
September 2013
Related Keywords:
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasms by Histologic Type
- Neoplasms
- Hemostatic Disorders
- Vascular Diseases
- Cardiovascular Diseases
- Paraproteinemias
- Blood Protein Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Immune System Diseases
- Vorinostat
- Bortezomib
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Analgesics
- Sensory System Agents
- Peripheral Nervous System Agents
- Physiological Effects of Drugs
- Pharmacologic Actions
- Anti-Inflammatory Agents
- Therapeutic Uses
- Antirheumatic Agents
- Antineoplastic Agents
- Enzyme Inhibitors
- Molecular Mechanisms of Pharmacological Action
- Anticarcinogenic Agents
- Multiple Myeloma
- Neoplasms, Plasma Cell
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