Study of Vorinostat With Doxil and Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01492881
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Oral, 400mg, taken days 4 through 11 of each cycle.
  • Bortezomib — DRUG
    subcutaneous injection, 1.3mg/m2, Days 1, 4, 8, and 11 every cycle
  • pegylated liposomal doxorubicin — DRUG
    Intravenous, 30mg/m2, Day 4

Study Details

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'.

Key Dates

Start date
Apr 30, 2012
Status verified
May 2012
Primary completion
Jan 31, 2015
Completion
Jan 31, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Estimate the overall response rate. [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill· Chapel Hill, NC

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