A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
2 other identifiers
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Dec 2003
Shorter than P25 for phase_1 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 22, 2005
CompletedFirst Posted
Study publicly available on registry
April 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2006
CompletedNovember 14, 2019
November 1, 2019
2.2 years
April 22, 2005
November 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- weeks or more from prior chemotherapy and have recovered from prior toxicities
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 18297527RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2005
First Posted
April 25, 2005
Study Start
December 1, 2003
Primary Completion
February 14, 2006
Study Completion
February 14, 2006
Last Updated
November 14, 2019
Record last verified: 2019-11