Multiple Mieloma Clinical Trial
Official title:
Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)
- Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic
malignancies. Between 50 and 70% of symptomatic patients presented response to
induction chemotherapy. The rate of complete responses (CR) achieved with standard
induction of these treatments is less than 5% of cases and the median event-free
survival between 2 and 3 years although most of the patients died from the disease.
- High dose chemotherapy with autologous stem cell transplant has improved the response
rate and survival of patient with MM. However eventually all patients relapse with a
median EFS between 40-50 months post-transplant.
- To improve these results and sustain remission, various maintenance treatment have been
proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits
in a meta-analysis.
- Intron A s.c. need administration of 3 days per week and is not well tolerated
- Recently a new formulation of Interpheron alpha2b is available. Conjugated with
polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in
MM.
- The purpose of this study is to evaluate the role of Pegintron as maintenance after
autologous transplant in MM
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment