Clinical Trials Logo
  1. Home
  2. Myeloma
  3. NCT00466674

Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning — IFM 2005-03  

Myeloma Clinical Trial

Official title:
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning (IFM 2005-03)

Clinical Trial Summary

Donor mobilization :

Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

Hematopoïetic Stem Cell Harvest:

By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >= 2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

- D-5 : Fludarabine (30 mg/m²)

- D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)

- D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)

- D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)

- D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer> 1/32.

Transplant : HSC at D0

• 3 months after Transplantation :

Disease Evaluation :

- If CR : Supervision. Then if progression: 4 cycles of Bortezomib.

- If no CR : Bortezomib (4 cycles)

• Evaluation after Bortezomib cycles

- If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00466674
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase Phase 2
Start date January 2007
Completion date September 2013
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03832127 - Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients Phase 1
Completed NCT01413178 - A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma Phase 3
Recruiting NCT03641456 - VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma Phase 2
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT03135925 - Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation N/A
Withdrawn NCT02114502 - Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma Phase 2
Completed NCT00800839 - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide Phase 2
Completed NCT01700608 - Prospective Observational Study on Plerixafor After Chemotherapy N/A
Completed NCT00794261 - Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Phase 2
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Recruiting NCT05528887 - Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies Phase 1
Recruiting NCT05625971 - Non-invasive MRD Assessment in Multiple Myeloma
Active, not recruiting NCT02931942 - Changing Over Time of Ascorbic Acid After Chemotherapy
Active, not recruiting NCT05889221 - Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Active, not recruiting NCT02542657 - Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT01191060 - Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Phase 3
Completed NCT01279694 - Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP) Phase 1/Phase 2
Terminated NCT00983346 - Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients Phase 2
Completed NCT00476294 - Long-Term Follow Up Study for AMD3100 Patients N/A