Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00461955
• Lead Sponsor: University Hospital, Bordeaux

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 vivo amplified graft, without transfusion.

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 hematopoietic reconstitution:

1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets

2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned

3. Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.

Study Timeline

• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Study First Posted: 2007-04-18
• Study Start: 2007-08
• Primary Completion: 2008-09
• Study Completion: 2009-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-03
• Last Update Posted: 2010-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.	at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft

Secondary Outcome Measures

Name	Time	Method
Immediate Toxicity of the injection of the amplified graft ;	just after the injection of the amplified graft
Quantitative immunological Reconstitution	at day 30, 100, 180, 270, 360 after the injection and then every 6 months
Stability of the hematopoiesis in the long term	at 1, 3, 6, 9 and 12 months after the graft
Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.	at 1, 3, 6, 9 and 12 months after the injection

Trial Locations

Locations (1)

CHU Haut-Leveque; 🇫🇷 Pessac, France