drugset / Trial / NCT00670631
Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-05
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 20 mg | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | tandem autologous transplantation | Unknown | 100 mg | — |
| Background | Cisplatin | Other / unclassified | 10 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 400 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 10 mg/m2 | — |
| Background | Etoposide | Small molecule | 40 mg/m2 | — |
| Background | Melphalan | Small molecule | 100 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | carmustine | Small molecule | 300 mg/m2 | — |