NCT02981199

Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chen Wenming · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.

Detailed description

NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.

Conditions

• Microtransplantation
• Autologous Stem Cell Transplantation
• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
PROCEDURE	stem cell transplantation	conditioning with chemotherapy \[VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)\], then stem cell transfusion

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-12-05
• Last updated: 2016-12-16

Locations

1 site across 1 country: China