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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461955
First Posted: April 18, 2007
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Bordeaux
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Immediate Toxicity of the injection of the amplified graft ; [ Time Frame: just after the injection of the amplified graft ]
  • Quantitative immunological Reconstitution [ Time Frame: at day 30, 100, 180, 270, 360 after the injection and then every 6 months ]
  • Stability of the hematopoiesis in the long term [ Time Frame: 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. [ Time Frame: at 1, 3, 6, 9 and 12 months after the injection ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 17, 2007
First Posted: April 18, 2007
Last Update Posted: November 4, 2010
Last Verified: November 2010

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