Status:
WITHDRAWN
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replac...
Detailed Description
A transplant of one's own bone marrow stem cells is part of a standard treatment for MM. Because MM comes from the bone marrow, stem-cell products from the bone marrow can have tumor cells mixed in th...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy
- Age 18 to 75 years
- Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias
- FEV1, FVC and DLCO \>/= 40%. No symptomatic pulmonary disease
- Serum bilirubin \</= 2 x upper limit of normal, SGPT \</= 4 x upper limit of normal
- HIV-negative
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation
Exclusion
- International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin \< 3.5 mg/L and albumin \>/= 3.5 g/dL)
- Patients with an apheresis collection \</= 7 x 10e6 CD34+/Kg
- A fully matched related donor
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00968396
Start Date
February 1 2013
Last Update
April 5 2013
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