Clinical trial · Interventional
Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
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
NCT00461955CI-TRIAL-00120965ExpansioncompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous peripheral blood stem cell transplantation, ex vivo amplified | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- autologous peripheral blood stem cell transplantation
- interventionNames
- Procedure: autologous peripheral blood stem cell transplantation, ex vivo amplified
Primary outcomes (1)
- measure
- 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.
- timeFrame
- at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft
Secondary outcomes (4)
- measure
- Immediate Toxicity of the injection of the amplified graft ;
- timeFrame
- just after the injection of the amplified graft
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDBernstein 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. PMID 1710148
- BACKGROUNDBodine 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. PMID 1714328
- BACKGROUNDBoiron 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. PMID 8104070
- BACKGROUNDBrandt 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. PMID 1697607
- BACKGROUNDBrugger 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. PMID 7541111
- BACKGROUNDHaylock 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. PMID 1381625
- BACKGROUNDIscove 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.