Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, High Risk, Intermediate Risk, Symptomatic
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Total Marrow Irradiation Type: Radiation
Name: Autologous Transplant Type: Procedure
Name: Melphalan Type: Drug
Name: Filgrastim (G-CSF) Type: Drug
Overall Status
Recruiting
Summary
In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients meeting criteria for symptomatic myeloma

- Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria:

- Durie Salmon stage 2 or 3 disease

- Abnormal metaphase cytogenetics

- Presence of FISH abnormalities aside from hyperdiploidy

- Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months

- Patient age 18-75 years at time of enrollment

- 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

- Renal: Creatinine clearance of >30mL/min, estimated or calculated

- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

Exclusion Criteria:

- Patients with the following will be ineligible for registration:

- Patients with diagnosis of plasma cell leukemia

- Patients with myeloma who have had any disease progression prior to enrollment

- 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.

- Patients who have undergone prior allograft or autologous transplant

- Prior solid organ transplant

- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Location
UIC Cancer Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Pritesh Patel, MD - 312-996-5762 - prpatel8@uic.edu
Start Date
December 2013
Completion Date
December 2017
Sponsors
University of Illinois at Chicago
Source
University of Illinois at Chicago
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page