Recruitment

Recruitment Status
Completed
Estimated Enrollment
18

Inclusion Criteria

Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Cardiac function: LVEF >40%
Karnofsky performance status of ≥70
...
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Cardiac function: LVEF >40%
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
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)
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Patient age 18-75 years at time of enrollment

Exclusion Criteria

Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas
...
Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Prior solid organ transplant
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.

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

Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Cardiac function: LVEF >40%
Karnofsky performance status of ≥70
...
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Cardiac function: LVEF >40%
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
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)
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Patient age 18-75 years at time of enrollment

Exclusion Criteria

Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas
...
Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Prior solid organ transplant
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.

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
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