A Phase 1 Dose Escalation Study of Bortezomib (Velcade®), Pegylated Liposomal Doxorubicin (Doxil®), and Vorinostat (Suberoylanilide Hydromaxic Acid, Saha, Zolinzatm) in Patients With Relapse/Refractory Multiple Myeloma
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Maximum tolerated dose of vorinostat
Study Overview
Brief Summary
RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride liposome together with vorinostat and bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and doxorubicin hydrochloride liposome in treating patients with relapsed or refractory multiple myeloma.
Detailed Description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of vorinostat when added to the standard regimen of bortezomib and pegylated liposomal doxorubicin hydrochloride in patients with relapsed or refractory multiple myeloma.
- To identify the dose-limiting toxicities of this regimen in these patients.
Secondary
- To gain preliminary evidence of antitumor activity of this regimen in these patients.
- To assess the degree of proteasome inhibition achieved with this regimen in these patients.
- To evaluate the accumulation of acetylated alpha-tubulin after treatment with vorinostat.
- To evaluate overall survival, time to progression, and progression-free survival of patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
Intervention: bortezomib (Drug)
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
Intervention: pegylated liposomal doxorubicin hydrochloride (Drug)
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
Intervention: vorinostat (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose of vorinostat
Time Frame: 4 years
Secondary Outcomes
- Overall response rate(5 years)
- Duration of response(5 years)