Tandem Autotransplantation for Multiple Myeloma in Participants With Less Than 12 Months of Preceding Therapy, Incorporating Velcade (Bortezomib) With the Transplant Chemotherapy and During Maintenance
This study is targeted towards patients who have been diagnosed with Multiple Myeloma,
POEMS(Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin
changes), or myeloma plus amyloidosis and have had no more than 12 months of prior
treatment. Furthermore, participants cannot have had a prior autologous or allogeneic
transplant. 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
- In contrast to Total Therapy II and III, which only allow enrollment of patients with
one cycle or one month of treatment prior to enrollment, the proposed study allows
enrollment of participants with up to 12 months of prior treatment.
- Induction therapy has been reduced to a single cycle.
- Bortezomib and thalidomide have been added to the transplant regimen.
- Carmustine is added to the second transplant.
- Gemcitabine is added to the second transplant regimen.
- Consolidation treatment has been reduced to a single cycle.
- The first year of maintenance consists of 12 28-day cycles of bortezomib,dexamethasone,
and either thalidomide, lenalidomide, or cyclophoshamide. The second year of
maintenance therapy consists of lenalidomide and dexamethasone.
- The novel agents thalidomide and bortezomib are not introduced upfront, but only with
transplantation, consolidation, and maintenance.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-Free Survival (EFS)
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Guido J Tricot, MD, PhD
University of Iowa
United States: Federal Government
|University of Iowa Holden Comprehensive Cancer Center||Iowa City, Iowa 52242|