Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
18

Inclusion Criteria

Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
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)
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Patient age 18-75 years at time of enrollment
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Cardiac function: LVEF >40%
Patients meeting criteria for symptomatic myeloma

Exclusion Criteria

Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Prior solid organ transplant
...
Patients with diagnosis of plasma cell leukemia
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
Pregnant or breast-feeding
Patients with truly non secretory myeloma (patients with light chain disease are eligible)
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: 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

Inclusion Criteria

Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
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)
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Patient age 18-75 years at time of enrollment
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Cardiac function: LVEF >40%
Patients meeting criteria for symptomatic myeloma

Exclusion Criteria

Patients with diagnosis of plasma cell leukemia
Patients who have undergone prior allogeneic stem cell transplant
Prior solid organ transplant
...
Patients with diagnosis of plasma cell leukemia
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
Pregnant or breast-feeding
Patients with truly non secretory myeloma (patients with light chain disease are eligible)
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.

Locations

Chicago, Illinois, 60612
Chicago, Illinois, 60612

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