Trial Information
A Multicenter, Open-Label, Phase I Study of MK0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
Inclusion Criteria:
- Patient Is 20 Years Of Age Or Older.
- Patient Has An Established Diagnosis Of Multiple Myeloma Based On The Myeloma
Diagnostic Criteria
- Patient Has Received At Least 1 But Not More Than 3 Prior Anti-Myeloma Regimens And
Has Progressive Disease After The Most Recent Treatment Regimen
- Patient Must Have Adequate Organ Function
Exclusion Criteria:
- Patient Has Had A Prior Allogeneic Bone Marrow Transplant Or Plans To Undergo Any
Type Of Bone Marrow Transplantation During The Study
- Patient Has Known Hypersensitivity To Any Components Of Bortezomib Or MK0683
- Patient Has Active Hepatitis B Or C, Plasma Cell Leukemia, Or Is Hiv Positive
- Patient Has Had Prior Treatment With MK0683 Or Hdac Inhibitors
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Any clinical or laboratory adverse experiences
Outcome Time Frame:
21 Days
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
2009_557
NCT ID:
NCT00858234
Start Date:
March 2009
Completion Date:
April 2012
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell