A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.
A total of up to 260 patients > 65 years old diagnosed of Multiple Myeloma with symptomatic
disease and that have not received previous chemotherapy for MM will be included.
Patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment,
Treatment and Follow up.
The Pre-treatment includes Screening and baseline visits. After providing informed consent,
patients will be evaluated for study eligibility and then Patients will be randomized one to
one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade
(Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks,
without progression and unacceptable toxicity, Patients will be again randomized one to one
to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade
(Group M2) during three years.
Once the treatment period has finished a follow up will be carry out. During this period we
will evaluated response, progression-free survival and global survival every three months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments
Lahuerta Juan josé, Dr
Hospital 12 de Octubre
Spain: Ministry of Health