Phase 1
N=12
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
Multiple Myeloma, Relapsed · Multiple Myeloma, Refractory to Standard Treatment
Bottom Line
View on ClinicalTrials.gov: NCT02043847 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Oct 2024
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Gy — NA Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Total Marrow Irradiation (Radiation); Melphalan (Drug); Filgrastim (G-CSF) (Drug); Autologous transplant (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Gy |
NA | — |
| SECONDARY Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation |
1; 1; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients meeting criteria for symptomatic myeloma
- Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- Cardiac function: LVEF >40%
- Hepatic: Bilirubin 30mL/min, estimated or calculated
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Exclusion Criteria
- Patients with diagnosis of plasma cell leukemia
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Pregnant or breast-feeding
- 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.
- Patients who have undergone prior allogeneic stem cell transplant
- Prior solid organ transplant
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Data sourced from ClinicalTrials.gov (NCT02043847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.