A Multicenter Phase II Study of Subcutaneous Velcade Plus Oral Melphalan and Prdnisone or Plus Cycloposphamide and Prednisone or Plus Prednisone in Newly Diagnosed Elderly Multiple Myeloma Patients
This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess
the safety and the efficacy of VMP and VCP and VP as up-front treatment in elderly MM
patients. The combination of weekly subcutaneous administrations of Velcade with continuous
low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and
prednisone (VCP) or Velcade with low-dose prednisone could be effective and well tolerated
Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment,
treatment and long-term follow-up (LTFU).
The pre-treatment period includes screening visits, performed at study entry. After
providing written informed consent to participate in the study, patients will be evaluated
for study eligibility. The screening period includes the availability of inclusion criteria
The treatment period includes induction and maintenance.
1. Induction therapy:
nine 4-week courses of Velcade/Melphalan/Prednisone (VMP) or nine 4-week courses of
Velcade/Cyclophosphamide/Prednisone (VCP) or Nine 4-week courses of Velcade/Prednisone
2. Maintenance therapy:
Velcade alone During the induction period patients will attend periodic study centre visits
each scheduled Velcade administration in order to asses the toxicity and efficacy of the
treatment. During the maintenance period, all patients will attend study centre visits every
4 weeks, until development of confirmed PD. The response will be assessed after each cycle.
During the LTFU period, after development of confirmed PD, all patients are to be followed
for survival during the LTFU period every 3 months via telephone or office visit.
The duration of treatment period, including the maintenance treatment is approximately 3
years. The duration of LTFU is approximately 2 years, for a total of 5 years. the occurance
of PD will determine the duration of progression-free survival of each patient(secondary
objective). The occurrence of death will determine the duration of overall survival
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Very Good Partial Response, Complete response rate , Partial response rate
Antonio Palumbo, MD
Division of Hematology, A.O.U. San Giovanni Battista
Italy: Ethics Committee