Clinical trial NCT00111813: Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Official title: Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-05-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean Duration of Treatment With Vorinostat
timeFrame: Day 1 to an event causing discontinuation from the study, assessed up to 29 months
Secondary outcomes:
measure: Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
timeFrame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
measure: Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
timeFrame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
measure: Clinical AE Summary
timeFrame: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
measure: Laboratory AE Summary
timeFrame: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Weber DM, Graef T, Hussein M, Sobecks RM, Schiller GJ, Lupinacci L, Hardwick JS, Jagannath S. Phase I trial of vorinostat combined with bortezomib for the treatment of relapsing and/or refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):319-24. doi: 10.1016/j.clml.2012.07.007.