The purpose of this study is to determine whether the association of ZMP is safe and provides benefits in patients with relapsed/refractory MM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
Dipartimento Medicina Clinica e Sperimentale
Padova, Italy
A.O.U. S. Giovanni Battista
Torino, Italy
Policlinico Universitario di Udine
Udine, Italy
Azienda Ospedaliera di Verona - Policlinico G.B. Rossi
Verona, Italy
The dose limiting toxicity (DLT)of Vorinostat with MP
Time frame: one year
The maximum tolerated dose (MTD) of Vorinostat in association with MP
Time frame: 1 year
A significant number of PR or higher (>40%) following the proposed ZMP therapy
Time frame: 1 year
Duration of Progression Free Survival
Time frame: 5 Years
Duration of Overall Survival
Time frame: 5 years
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