Recruitment

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
Patients meeting criteria for symptomatic myeloma
Karnofsky performance status of ≥70
...
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Patients meeting criteria for symptomatic myeloma
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
Cardiac function: LVEF >40%
Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
Patient age 18-75 years at time of enrollment
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

Exclusion Criteria

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.
Patients with diagnosis of plasma cell leukemia
...
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.
Patients with diagnosis of plasma cell leukemia
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Patients with myeloma who have had any disease progression prior to enrollment
Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allograft or autologous transplant

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
Patients meeting criteria for symptomatic myeloma
Karnofsky performance status of ≥70
...
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Patients meeting criteria for symptomatic myeloma
Karnofsky performance status of ≥70
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
Cardiac function: LVEF >40%
Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
Patient age 18-75 years at time of enrollment
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

Exclusion Criteria

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.
Patients with diagnosis of plasma cell leukemia
...
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.
Patients with diagnosis of plasma cell leukemia
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Patients with myeloma who have had any disease progression prior to enrollment
Prior solid organ transplant
Pregnant or breast-feeding
Patients who have undergone prior allograft or autologous transplant

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
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