Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
NCT ID: NCT00461955
Last Updated: 2010-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
autologous peripheral blood stem cell transplantation
autologous peripheral blood stem cell transplantation, ex vivo amplified
autologous peripheral blood stem cell transplantation, ex vivo amplified
Interventions
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autologous peripheral blood stem cell transplantation, ex vivo amplified
autologous peripheral blood stem cell transplantation, ex vivo amplified
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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University Hospital, Bordeaux
Principal Investigators
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Noel MILPIED, MS, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU Haut-Leveque
Pessac, , France
Countries
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References
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Bernstein ID, Andrews RG, Zsebo KM. Recombinant human stem cell factor enhances the formation of colonies by CD34+ and CD34+lin- cells, and the generation of colony-forming cell progeny from CD34+lin- cells cultured with interleukin-3, granulocyte colony-stimulating factor, or granulocyte-macrophage colony-stimulating factor. Blood. 1991 Jun 1;77(11):2316-21.
Bodine DM, Crosier PS, Clark SC. Effects of hematopoietic growth factors on the survival of primitive stem cells in liquid suspension culture. Blood. 1991 Aug 15;78(4):914-20.
Boiron JM, Marit G, Faberes C, Cony-Makhoul P, Foures C, Ferrer AM, Cristol G, Sarrat A, Girault D, Reiffers J. Collection of peripheral blood stem cells in multiple myeloma following single high-dose cyclophosphamide with and without recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Bone Marrow Transplant. 1993 Jul;12(1):49-55.
Brandt J, Srour EF, van Besien K, Briddell RA, Hoffman R. Cytokine-dependent long-term culture of highly enriched precursors of hematopoietic progenitor cells from human bone marrow. J Clin Invest. 1990 Sep;86(3):932-41. doi: 10.1172/JCI114795.
Brugger W, Heimfeld S, Berenson RJ, Mertelsmann R, Kanz L. Reconstitution of hematopoiesis after high-dose chemotherapy by autologous progenitor cells generated ex vivo. N Engl J Med. 1995 Aug 3;333(5):283-7. doi: 10.1056/NEJM199508033330503.
Haylock DN, To LB, Dowse TL, Juttner CA, Simmons PJ. Ex vivo expansion and maturation of peripheral blood CD34+ cells into the myeloid lineage. Blood. 1992 Sep 15;80(6):1405-12.
Iscove NN, Shaw AR, Keller G. Net increase of pluripotential hematopoietic precursors in suspension culture in response to IL-1 and IL-3. J Immunol. 1989 Apr 1;142(7):2332-7.
Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31. doi: 10.1111/j.1537-2995.2005.00675.x.
Kobayashi M, Imamura M, Gotohda Y, Maeda S, Iwasaki H, Sakurada K, Kasai M, Hapel AJ, Miyazaki T. Synergistic effects of interleukin-1 beta and interleukin-3 on the expansion of human hematopoietic progenitor cells in liquid cultures. Blood. 1991 Oct 15;78(8):1947-53.
Moore MA. Review: Stratton Lecture 1990. Clinical implications of positive and negative hematopoietic stem cell regulators. Blood. 1991 Jul 1;78(1):1-19. No abstract available.
Moore MA. Hematopoietic reconstruction: new approaches. Clin Cancer Res. 1995 Jan;1(1):3-9. No abstract available.
Muench MO, Moore MA. Accelerated recovery of peripheral blood cell counts in mice transplanted with in vitro cytokine-expanded hematopoietic progenitors. Exp Hematol. 1992 Jun;20(5):611-8.
Muench MO, Schneider JG, Moore MA. Interactions among colony-stimulating factors, IL-1 beta, IL-6, and kit-ligand in the regulation of primitive murine hematopoietic cells. Exp Hematol. 1992 Mar;20(3):339-49.
Reiffers J, Marit G, Vezon G, Cony-Makhoul P, Boiron JM, Montastruc M, Rice A, Broustet A. Autologous blood stem cell grafting in hematological malignancies. Present status and future directions. Transfus Sci. 1992;13(4):399-405. doi: 10.1016/0955-3886(92)90024-B. No abstract available.
Reiffers J, Faberes C, Boiron JM, Marit G, Foures C, Ferrer AM, Cony-Makhoul P, Puntous M, Bernard P, Vezon G, et al. Peripheral blood progenitor cell transplantation in 118 patients with hematological malignancies: analysis of factors affecting the rate of engraftment. J Hematother. 1994 Fall;3(3):185-91. doi: 10.1089/scd.1.1994.3.185.
Rice A, Boiron JM, Barbot C, Dupouy M, Dubsoc-Marchenay N, Dumain P, Lacombe F, Reiffers J. Cytokine-mediated expansion of 5-FU resistant peripheral blood stem cells and bone marrow: self-renewal and commitment capacity. J Hematother. 1994 Summer;3(2):135-9. doi: 10.1089/scd.1.1994.3.135.
Shih JP, Ogawa M. Monoclonal antibody J11d.2 recognizes cell cycle-dormant, primitive hematopoietic progenitors of mice. Blood. 1993 Mar 1;81(5):1155-60.
Smith C, Gasparetto C, Collins N, Gillio A, Muench MO, O'Reilly RJ, Moore MA. Purification and partial characterization of a human hematopoietic precursor population. Blood. 1991 May 15;77(10):2122-8.
Other Identifiers
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CHUBX 2000/04
Identifier Type: -
Identifier Source: org_study_id