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

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

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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

- 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:


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:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

May 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell