NCT00984828

Randomized Study of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients

A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.

Detailed description

The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. Newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and Dexamethasone as front-line induction therapy. All patients finished the induction therapy will be randomized into standard group and the study group. All patients will mobilized by cyclophosphamide with G-CSF to collect a target of 2x106 CD34+/kg and then undergo autologous stem cell transplantation. For standard group, patients will receive single auto-SCT with standard conditioning of melphalan 200mg/m2. The patients in the study group will receive single auto-SCT with conditioning of melphalan 200mg/m2 added with 4 dose of velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles of velcade alone as consolidation.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	velcade	velcade 1.3mg/m2 D1, 4, 8 and 11

Timeline

• Start date: 2009-08-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2009-09-25
• Last updated: 2016-09-08

Locations

1 site across 1 country: China