drugset / Trial / NCT02043860
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.
Timeline
- Start
- 2014-01-10
- Primary completion
- 2016-11-07
- Completion
- 2016-11-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Melphalan | Small molecule | 200 mg/m2 | — |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |