Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Conditions
Multiple Myeloma, Relapsed - Multiple Myeloma, Refractory to Standard Treatment
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Relapsed, Refractory, Progressive Disease, 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: Melphalan Type: Drug
Name: Filgrastim (G-CSF) Type: Drug
Overall Status
Recruiting
Summary
In this phase I trial, patients with relapsed or refractory 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 9Gy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients who meet the following criteria will be eligible

- 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)

- 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 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 allogeneic stem cell transplant

- Prior solid organ transplant

- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Location
University of Illinois 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