Recruitment

Recruitment Status
Completed
Estimated Enrollment
18

Inclusion Criteria

Cardiac function: LVEF >40%
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
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
Karnofsky performance status of ≥70
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
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Patients meeting criteria for symptomatic myeloma
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

Exclusion Criteria

Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allogeneic stem cell transplant
...
Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allogeneic stem cell transplant
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 with truly non secretory myeloma (patients with light chain disease are eligible)
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Patients with diagnosis of plasma cell leukemia

Summary

Conditions
  • Multiple Myeloma, Refractory to Standard Treatment
  • Multiple Myeloma, Relapsed
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Inclusion Criteria

Cardiac function: LVEF >40%
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
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
Karnofsky performance status of ≥70
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
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Patients meeting criteria for symptomatic myeloma
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

Exclusion Criteria

Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allogeneic stem cell transplant
...
Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allogeneic stem cell transplant
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 with truly non secretory myeloma (patients with light chain disease are eligible)
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Patients with diagnosis of plasma cell leukemia

Tracking Information

NCT #
NCT02043847
Collaborators
Not Provided
Investigators
  • Principal Investigator: Pritesh Patel, MD University of Illinois at Chicago
  • Pritesh Patel, MD University of Illinois at Chicago