Study of Vorinostat Plus Melphalan and Prednisone (Zmp) in Advanced, Refractory Multiple Myeloma Patients

Sponsor
Tiziana Marangon
Study ID
NCT00857324
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Patients will start induction treatment with a standard dose of MP and escalating doses of Vorinostat: * Melphalan 0.18 mg/Kg for 4 days; Prednisone 1.5 mg/Kg for 4 days. Each cycle will be repeated every 28 days for a total of 6 courses * In the first part of the study, the standard oral MP will be combined with escalating doses of Vorinostat. Level -1 Vorinostat = 100 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level 0 Vorinostat = 200 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level +1 Vorinostat = 300 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4 Level +2 Vorinostat = 400 mg daily on days 1-21 Melphalan = 0.18 mg/kg on days 1 - 4 Prednisone = 1.5 mg/kg on days 1 - 4

Study Details

The purpose of this study is to determine whether the association of ZMP is safe and provides benefits in patients with relapsed/refractory MM.

Key Dates

Start date
Mar 31, 2009
Status verified
Sep 2017
Primary completion
Mar 31, 2012
Completion
May 31, 2017

Study Design

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

Arms

  • Experimental: ZMP
    Combination with Vorinostat, Melphalan and Prednisone

Primary Outcome Measure

The dose limiting toxicity (DLT)of Vorinostat with MP [ Time Frame: one year ]

Related Studies