Know Cancer

or
forgot password

A Multicenter, Open-Label, Phase I Study of MK0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma


Phase 1
20 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

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

Name

Location