drugset / Trial / NCT00028600
Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Phase 2
Completed
60 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
Timeline
- Start
- 2001-11
- Primary completion
- 2006-06
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD34+ cells | Unknown | 2e+06 cells/kg | Intravenous |
| Subject | CD34+ cells | Unknown | 8e+06 cells/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 4000 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 200 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |