Status:
COMPLETED
Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Hematopoietic reconstitution defined by a neutrophils number \> 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number \> 20000/mm3, at day 15 after the injection of ex ...
Detailed Description
To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoieti...
Eligibility Criteria
Inclusion
- Patient between 18 and 65 years of age
- Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation
- Performance status: \< 2 (Karnofsky \> 70%)
- Anticipated survival \> 3 month
- Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis.
- Signed and dated informed consent
Exclusion
- Multiple Myeloma not requiring a treatment
- Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
- Positive serology for HIV, hepatitis C or hepatitis B
- Hepato cellular insufficiency
- Severe renal insufficiency defined by a creatine clearance \< 30 ml/mn
- Women pregnant or nursing, or effective absence of contraception
- Antecedent of serious cardiac disease in the last 6 months.
- Allergy known to the products derived from Escherichia Coli
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00461955
Start Date
August 1 2007
End Date
August 1 2009
Last Update
November 4 2010
Active Locations (1)
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1
CHU Haut-Leveque
Pessac, France, 33604