NCT00892346

Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.

Detailed description

This is an open label clinical trial to evaluate the efficacy of single autologous hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. All patients will receive 4-6 cycles of induction therapy which includes VAD chemotherapy (vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. After peripheral hematopoietic stem cell mobilization and apheresis, patients will receive a standard conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at 100-200mg orally daily starting from D+60 till disease progression or untolerable toxicity.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Single ASCT with Thalidomide maintenance	Single ASCT with Thalidomide maintenance: 1. Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv) 2. Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral)

Timeline

• Start date: 2009-05-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2009-05-04
• Last updated: 2016-05-10

Locations

1 site across 1 country: China