Clinical trial NCT00461955: Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Symptomatic Multiple Myeloma
first line treatment
first autologous Stem Cell Transplantation
ex vivo amplified autologous peripheral blood stem cells
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft
Secondary outcomes:
measure: Immediate Toxicity of the injection of the amplified graft ;
timeFrame: just after the injection of the amplified graft
measure: Quantitative immunological Reconstitution
timeFrame: at day 30, 100, 180, 270, 360 after the injection and then every 6 months
measure: Stability of the hematopoiesis in the long term
timeFrame: at 1, 3, 6, 9 and 12 months after the graft
measure: Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term.
timeFrame: at 1, 3, 6, 9 and 12 months after the injection
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Haut-Leveque
Study officials:
affiliation: University Hospital, Bordeaux
name: Noel MILPIED, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
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