Clinical trial · Interventional
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
NCT02043847CI-TRIAL-00082488BMT-03completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
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, Refractory to Standard Treatment | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Multiple Myeloma, Relapsed | Multiple Myeloma | CURATED_BROADER | 0.78 |
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 (3)
- type
- EXPERIMENTAL
- label
- Cohort 1Total Marrow Irradiation (TMI) 3Gy
- description
- 3Gy with standard high dose melphalan prior to autologous stem cell rescue
- interventionNames
- Radiation: Total Marrow Irradiation
- Drug: Melphalan
- Drug: Filgrastim (G-CSF)
- Procedure: Autologous transplant
- type
- EXPERIMENTAL
- label
- Cohort 2 Total Marrow Irradiation (TMI) 6Gy
- description
- 6Gy with standard high dose melphalan prior to autologous stem cell rescue
- interventionNames
- Radiation: Total Marrow Irradiation
- Drug: Melphalan
- Drug: Filgrastim (G-CSF)
- Procedure: Autologous transplant
- type
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 who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant) 3. Patient age 18-75 years at time of enrollment 4. Karnofsky performance status of ≥70 5. Cardiac function: LVEF \>40% 6. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal 7. Renal: Creatinine clearance of \>30mL/min, estimated or calculated 8. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin) Exclusion Criteria: 1. Patients with diagnosis of plasma cell leukemia 2. Patients with truly non secretory myeloma (patients with light chain disease are eligible) 3. Pregnant or breast-feeding 4. 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. 5. Patients who have undergone prior allogeneic stem cell transplant 6. Prior solid organ transplant 7. Patients receiving prior radiation to more than 20% of bone marrow containing areas
References
Publications (1)
- DERIVEDPatel P, Oh AL, Koshy M, Sweiss K, Saraf SL, Quigley JG, Khan I, Mahmud N, Hacker E, Ozer H, Peace DJ, Weichselbaum RR, Aydogan B, Rondelli D. A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m2 and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. Leuk Lymphoma. 2018 Jul;59(7):1666-1671. doi: 10.1080/10428194.2017.1390231. Epub 2017 Oct 25. PMID 29065747