Multiple Myeloma Clinical Trial
— ExpansionOfficial 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
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | August 2009 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Haut-Leveque | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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. — View Citation
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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. Retraction in: Kanz L, Brugger W. N Engl J Med. 2001 Jul 5;345(1):64. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft | Yes | |
Secondary | Immediate Toxicity of the injection of the amplified graft ; | just after the injection of the amplified graft | Yes | |
Secondary | Quantitative immunological Reconstitution | at day 30, 100, 180, 270, 360 after the injection and then every 6 months | Yes | |
Secondary | Stability of the hematopoiesis in the long term | at 1, 3, 6, 9 and 12 months after the graft | Yes | |
Secondary | Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term. | at 1, 3, 6, 9 and 12 months after the injection | Yes |
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