Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1Total Marrow Irradiation (TMI) 3Gy 3Gy with standard high dose melphalan prior to autologous stem cell rescue |
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
Other Names:
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.
Other Names:
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
|
Experimental: Cohort 2 Total Marrow Irradiation (TMI) 6Gy 6Gy with standard high dose melphalan prior to 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
Other Names:
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
Other Names:
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
|
Experimental: Cohort 3 Total Marrow Irradiation (TMI) 9Gy 9Gy with standard high dose melphalan prior to 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
Other Names:
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
Other Names:
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
|
Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose of TMI [Up to 60 days post-transplant.]
To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant for relapsed/ refractory myeloma.
Secondary Outcome Measures
- Progression Free Survival [Up to 1 year post-transplant.]
To evaluate 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.
Eligibility Criteria
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 <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
-
Renal: Creatinine clearance of >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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Pritesh Patel, MD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-0201
- 2013-0201