A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old
A total of up to 390 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
(1:1:1) to receive VBMCP-VBAD+Velcade (Group A) or Thalidomide+Dexamethasone (Group B) or
Thalidomide+Dexamethasone+Velcade (Group C). All of them will received the induction
treatment up to 24 weeks.
After 4 weeks, without progression or unacceptable toxicity, There will be stem cell
mobilization to do an autologous transplant. Three months after transplant, patients will be
again randomized (1:1:1) to receive maintenance treatment: Interferon-a (Group M1) or
Thalidomide (Group M2) or Thalidomide+Velcade (Group M3) 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 compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.
Bladé Joan, Dr
HOSPITAL CLÍNIC BARCELONA
Spain:Spanish Ministry of Health