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

University Hospital of Bordeaux

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified

Study type: Interventional

Funder types: Other

Identifiers

NCT00461955

CHUBX 2000/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Description:

autologous peripheral blood stem cell transplantation

Treatment:

Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified