Clinical trial · Interventional
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
BMT-02: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Multiple Myeloma Following Initial Induction Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Transplant | Procedure | — | UNRESOLVED |
| Filgrastim (G-CSF) | Drug | Filgrastim | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Total Marrow Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Total Marrow Irradiation
- description
- Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
- interventionNames
- Radiation: Total Marrow Irradiation
- Procedure: Autologous Transplant
- Drug: Melphalan
- Drug: Filgrastim (G-CSF)
Primary outcomes (1)
- measure
- Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze
- timeFrame
- Up to 1 year post-transplant.
- description
- To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients meeting criteria for symptomatic myeloma 2. Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy 3. Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months 4. Patient age 18-75 years at time of enrollment 5. Karnofsky performance status of ≥70 6. Cardiac function: LVEF \>40% 7. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal 8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated 9. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin) Exclusion Criteria: 1. Patients with diagnosis of plasma cell leukemia 2. Patients with myeloma who have had any disease progression prior to enrollment 3. Patients with truly non secretory myeloma (patients with light chain disease are eligible) 4. Pregnant or breast-feeding 5. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis. 6. Patients who have undergone prior allograft or autologous transplant 7. Prior solid organ transplant 8. Patients receiving prior radiation to more than 20% of bone marrow containing areas
References
Publications (0)
Data not yet available