Tandem Autotransplantation for Multiple Myeloma Patients With Less Than 12 Months of Preceding Therapy, Incorporating Bortezomib With the Transplant Chemotherapy and During Maintenance
This study is targeted towards patients who have been diagnosed with Multiple Myeloma and
have had no prior autologous or allogeneic transplant. Furthermore, only up to 12 months of
prior treatment are allowed in this patient population. The study schema consists of one
round of induction chemotherapy, two transplants, one round of consolidation chemotherapy,
and two years of maintenance treatment. This study design differs from its historical
predecessors in the following manner:
- In contrast to Total Therapy II and III, which only allow enrollment of patients with
at most one cycle or one month of treatment prior to enrollment, the proposed study
allows enrollment of patients with up to 12 months of prior treatment. No statistically
significant difference in outcome between patients with one or no cycle of preceding
therapy and those with up to 12 months of prior therapy. This should allow enrollment
of significantly more myeloma patients.
- Induction therapy has been reduced to a single cycle.
- Bortezomib and thalidomide have been added to the transplant regimen.
- BCNU is added to the second transplant to high dose melphalan.
- Gemcitabine is added to the second transplant regimen.
- Consolidation treatment has been reduced to a single cycle.
- The first year of maintenance is with bortezomib, thalidomide and dexamethasone, and
the second year of maintenance therapy consists of dexamethasone only.
- The novel agents thalidomide and bortezomib are not introduced upfront, but only with
transplantation and maintenance.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether, in comparison to TT II, the median EFS can be increased from 4.8 years to 6.2 years, which represents an increase in median EFS of approximately 30%
After enrollment of 204 subjects is completed
Guido J Tricot, MD, PhD
University of Utah
United States: Institutional Review Board