Multiple Myeloma
Conditions
Keywords
Symptomatic Multiple Myeloma, first line treatment, first autologous Stem Cell Transplantation, ex vivo amplified autologous peripheral blood stem cells
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.
Interventions
PROCEDUREautologous peripheral blood stem cell transplantation, ex vivo amplified
autologous peripheral blood stem cell transplantation, ex vivo amplified
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNoel MILPIED, MS, MD
University Hospital, Bordeaux
Outcome results
None listed