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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft

Safety Issue:

Yes

Principal Investigator

Noel MILPIED, MS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2000/04

NCT ID:

NCT00461955

Start Date:

August 2007

Completion Date:

August 2009

Related Keywords:

  • Multiple Myeloma
  • Symptomatic Multiple Myeloma
  • first line treatment
  • first autologous Stem Cell Transplantation
  • ex vivo amplified autologous peripheral blood stem cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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