Recruitment

Recruitment Status
Terminated
Estimated Enrollment
24

Inclusion Criterias

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

Exclusion Criterias

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

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 Criterias

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

Exclusion Criterias

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

Locations

Chicago, Illinois, 60612
Chicago, Illinois, 60612

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