Trials / Completed
CompletedNCT02043847
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- University of Illinois at Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
Detailed description
In this phase I trial, patients with relapsed or refractory 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 9Gy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Total Marrow Irradiation | Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day |
| DRUG | Melphalan | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant |
| DRUG | Filgrastim (G-CSF) | Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. |
| PROCEDURE | Autologous transplant | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| RADIATION | Total Marrow Irradiation | Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day |
| DRUG | Melphalan | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant |
| DRUG | Filgrastim (G-CSF) | Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days |
| PROCEDURE | Autologous transplant | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| RADIATION | Total Marrow Irradiation | Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day |
| DRUG | Melphalan | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant |
| DRUG | Filgrastim (G-CSF) | Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days |
| PROCEDURE | Autologous transplant | Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue |
Timeline
- Start date
- 2014-01-14
- Primary completion
- 2016-09-14
- Completion
- 2016-09-14
- First posted
- 2014-01-23
- Last updated
- 2024-11-13
- Results posted
- 2024-10-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02043847. Inclusion in this directory is not an endorsement.