Study of Vorinostat With Doxil and Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
Drug: pegylated liposomal doxorubicin
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Single-Arm, Phase II Study of Vorinostat (V) in Combination With Pegylated Liposomal Doxorubicin (PLD) and Bortezomib (B) Followed by VB Maintenance in Patients With Relapsed and Relapsed/Refractory Multiple Myeloma|
- Estimate the overall response rate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]Estimate the overall response rate (ORR) of the vorinostat, PLD and bortezomib regimen (VB/PLD) followed by vorinostat/bortezomib (VB) maintenance in patients with relapsed and relapsed/refractory multiple myeloma. Criteria for response will be based on the International Uniform Response Criteria for Multiple Myeloma, modified to incorporate criteria for minor response (MR). The overall response rate will be defined as the total number of patients whose response are PR or above, divided by the number of response evaluable patients.
- Evaluate the quality of life measures in patients. [ Time Frame: 18 months ] [ Designated as safety issue: No ]QOL will be evaluated using the EORTC QLQ-C30 and QLQ-MY20 survey instruments.
- Assess the safety and tolerability. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Safety will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE v4). The analysis of safety will be based on the frequency of adverse events and their severity for patients who received any study medicine.
- Estimate the overall survival. [ Time Frame: 36 months ] [ Designated as safety issue: No ]A patient's survival time will be defined as the time from start of treatment to the date of his or her death.
- Estimate Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]A patient's progression-free survival (PFS) will be defined as the time from start of treatment until the date he or she has documented progression or dies.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Vorinostat, Bortezomib, Doxil
Induction therapy will consist of up to 8 cycles of vorinostat, bortezomib, and doxil. One cycle is defined as 21 days.
Maintenance therapy will consist of Vorinostat and bortezomib. One maintenance cycle is 28 days and repeated for up to 1 year.
Oral, 400mg, taken days 4 through 11 of each cycle.
Other Name: ZolinaDrug: Bortezomib
subcutaneous injection, 1.3mg/m2, Days 1, 4, 8, and 11 every cycle
Other Name: VelcadeDrug: pegylated liposomal doxorubicin
Intravenous, 30mg/m2, Day 4
Other Name: Doxil
This is a prospective, open-label single arm phase II trial of vorinostat, bortezomib and pegylated liposomal doxorubicin (PLD) followed by vorinostat/bortezomib (VB) maintenance therapy for patients with relapsed and relapsed and refractory multiple myeloma (MM). The primary hypothesis being evaluated is that the addition of vorinostat to the PLD and bortezomib backbone (VB-PLD) will improve the overall response rate (ORR) as compared to a historical control of PLD in combination with bortezomib. We anticipate that the addition of maintenance therapy will not improve the ORR, but may improve the quality (depth) of response and progression free survival (PFS).
Secondary endpoints include PFS, high quality response rates (very good partial responses (VGPR) + complete responses (CRs)), duration of remission (DOR), quality of life (QOL), overall survival (OS) and tolerability of the regimen in patients with relapsed and relapsed and refractory multiple myeloma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492881
|United States, North Carolina|
|Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Peter M Voorhees, MD||Lineberger Comprehensive Cancer Center at University of North Carolina at Chapel Hill|