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

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ClinicalTrials.gov Identifier: NCT00461955
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : November 4, 2010
Sponsor:
Information provided by:
University Hospital, Bordeaux

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Immediate Toxicity of the injection of the amplified graft ; [ Time Frame: just after the injection of the amplified graft ]
  2. Quantitative immunological Reconstitution [ Time Frame: at day 30, 100, 180, 270, 360 after the injection and then every 6 months ]
  3. Stability of the hematopoiesis in the long term [ Time Frame: at 1, 3, 6, 9 and 12 months after the graft ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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 Posted: April 18, 2007    Key Record Dates
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