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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00461955
First received: April 17, 2007
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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. [ Time Frame: at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immediate Toxicity of the injection of the amplified graft ; [ Time Frame: just after the injection of the amplified graft ] [ Designated as safety issue: Yes ]
  • Quantitative immunological Reconstitution [ Time Frame: at day 30, 100, 180, 270, 360 after the injection and then every 6 months ] [ Designated as safety issue: Yes ]
  • Stability of the hematopoiesis in the long term [ Time Frame: at 1, 3, 6, 9 and 12 months after the graft ] [ Designated as safety issue: Yes ]
  • Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term. [ Time Frame: at 1, 3, 6, 9 and 12 months after the injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
autologous peripheral blood stem cell transplantation
Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified
autologous peripheral blood stem cell transplantation, ex vivo amplified

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461955

Locations
France
CHU Haut-Leveque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Noel MILPIED, MS, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00461955     History of Changes
Other Study ID Numbers: CHUBX 2000/04
Study First Received: April 17, 2007
Last Updated: November 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Symptomatic Multiple Myeloma
first line treatment
first autologous Stem Cell Transplantation
ex vivo amplified autologous peripheral blood stem cells

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014