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
- 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.
- 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
- To evaluate the accumulation of acetylated alpha-tubulin after treatment with
- To evaluate overall survival, time to progression, and progression-free survival of
patients treated with this regimen.
OUTLINE: This is a multicenter, dose escalation study of vorinostat.
Patients receive oral vorinostat once daily on days 1,2; 4,5; 8, 9; 11, 12; bortezomib IV on
days 1, 4, 8, and 11, and pegylated liposomal doxorubicin hydrochloride IV on day 4. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for proteasome inhibition assays and acetylated
After completion of study treatment, patients are followed at 1 and 3 months.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of vorinostat
Peter Voorhees, MD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Mount Sinai Medical Center||New York, New York 10029|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|