Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: vorinostat (Drug); bortezomib (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat
and bortezomib in participants with advanced multiple myeloma
- To assess the safety and tolerability of this regimen and to document the participant's
clinical status (by anti-tumor activity) for this combination, as determined per
standard of care.
Clinical Details
Official title: Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Duration of Treatment With Vorinostat
Secondary outcome: Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study DrugMean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib Clinical AE Summary Laboratory AE Summary
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
treatment
- 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
Locations and Contacts
Additional Information
Starting date: September 2005
Last updated: May 5, 2015
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