Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
1 other identifier
interventional
N/A
0 countries
N/A
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 replacing the bone marrow after standard treatment with chemotherapy.
Trial Health
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
August 31, 2009
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedApril 5, 2013
April 1, 2013
2 years
August 27, 2009
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neutrophil Engraftment Rate
28 Days
Study Arms (1)
Stem Cell Collection + Transplantation
EXPERIMENTALApheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m\^2 IV over 30 minutes daily on Days -2 and -1.
Interventions
On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.
Co-culture Stem Cell Infusion on Day 0.
100 mg/m\^2 IV over 30 minutes daily on Days -2 and -1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yago Nieto, MD, PHD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2009
First Posted
August 31, 2009
Study Start
February 1, 2013
Primary Completion
February 1, 2015
Last Updated
April 5, 2013
Record last verified: 2013-04