Multiple Myeloma Clinical Trial
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
The purpose of this research study is to determine how multiple myeloma responds when the study drug vorinostat is added to the standard treatment of bortezomib and pegylated liposomal doxorubicin (PLD). After participants complete the three drug combination and if their multiple myeloma has decreased, the investigators also want to learn what effects (both good and bad) when vorinostat and bortezomib are given to people with multiple myeloma over a longer period of time. This type of treatment is called 'Maintenance Therapy'.
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.[1] 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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