Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 24
Inclusion Criteria
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
- Patients meeting criteria for symptomatic myeloma
- ...
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
- Patients meeting criteria for symptomatic myeloma
- Cardiac function: LVEF >40%
- Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- 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
- Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
Exclusion Criteria
- Patients with myeloma who have had any disease progression prior to enrollment
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Patients with diagnosis of plasma cell leukemia
- ...
- Patients with myeloma who have had any disease progression prior to enrollment
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Patients with diagnosis of plasma cell leukemia
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
- Patients who have undergone prior allograft or autologous transplant
- Prior solid organ transplant
- 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.
Summary
- Conditions
- Multiple Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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.
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.
Inclusion Criteria
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
- Patients meeting criteria for symptomatic myeloma
- ...
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
- Patients meeting criteria for symptomatic myeloma
- Cardiac function: LVEF >40%
- Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- 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
- Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
Exclusion Criteria
- Patients with myeloma who have had any disease progression prior to enrollment
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Patients with diagnosis of plasma cell leukemia
- ...
- Patients with myeloma who have had any disease progression prior to enrollment
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Patients with diagnosis of plasma cell leukemia
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
- Patients who have undergone prior allograft or autologous transplant
- Prior solid organ transplant
- 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.
Tracking Information
- NCT #
- NCT02043860
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pritesh Patel, MD University of Illinois at Chicago
- Pritesh Patel, MD University of Illinois at Chicago