A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG) Adequate bone marrow reserve Adequate hepatic and renal function Ability to swallow capsules 3 weeks or more from prior chemotherapy and have recovered from prior toxicities Exclusion Criteria: Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism Patients with other active/uncontrolled clinically significant illnesses Pregnant or nursing female patients
Sites / Locations
Outcomes
Primary Outcome Measures
PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Secondary Outcome Measures
1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
Full Information
NCT ID
NCT00109109
First Posted
April 22, 2005
Last Updated
November 13, 2019
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00109109
Brief Title
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Official Title
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Study Start Date
December 1, 2003 (Actual)
Primary Completion Date
February 14, 2006 (Actual)
Study Completion Date
February 14, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are:
To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
Primary Outcome Measure Information:
Title
PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
Title
PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Secondary Outcome Measure Information:
Title
1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
Adequate bone marrow reserve
Adequate hepatic and renal function
Ability to swallow capsules
3 weeks or more from prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria:
Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
Patients with other active/uncontrolled clinically significant illnesses
Pregnant or nursing female patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18297527
Citation
Richardson P, Mitsiades C, Colson K, Reilly E, McBride L, Chiao J, Sun L, Ricker J, Rizvi S, Oerth C, Atkins B, Fearen I, Anderson K, Siegel D. Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. Leuk Lymphoma. 2008 Mar;49(3):502-7. doi: 10.1080/10428190701817258.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
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