Multiple Myeloma Clinical Trial
Official title:
Tandem Autotransplantation for Multiple Myeloma Patients With Less Than 12 Months of Preceding Therapy, Incorporating Bortezomib With the Transplant Chemotherapy and During Maintenance
The two objectives of this study are:
- To increase the 2-year event-free survival from 55%, established with Total Therapy II
(UARK 98-026), to 75% in myeloma patients with cytogenetic abnormalities, and from 80%,
established with the Total Therapy II regimen, to 95% in myeloma patients without
cytogenetic abnormalities.
- To determine whether bortezomib, thalidomide, and dexamethasone can be safely
incorporated with transplant 1 into the established pre-transplant regimen of high-dose
melphalan (used in Total Therapy II) and whether Velcade and gemcitabine can be safely
added to the transplant 2 high-dose chemotherapy regimen of combination melphalan and
BCNU.
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.
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