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

Study Overview
=================
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: Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.

Official Title
-----------------
Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>autologous peripheral blood stem cell transplantation | Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified<br>* autologous peripheral blood stem cell transplantation, ex vivo amplified<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic Multiple Myeloma, first line treatment, first autologous Stem Cell Transplantation, ex vivo amplified autologous peripheral blood stem cells