A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients

NCT00899847 Phase 2 COMPLETED Results posted

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Details

Lead sponsor	Stanford University
Phase	Phase 2
Status	COMPLETED
Enrolment	9
Start date	2009-05
Completion	2014-12

Conditions

• Transplantation, Homologous
• Transplantation, Autologous
• Multiple Myeloma
• Blood and Marrow Transplant (BMT)

Interventions

• Autologous peripheral blood stem cells (auto-PBSC) transplantation
• Allogeneic peripheral blood stem cells (allo-PBSC) transplantation
• Filgrastim
• Cyclophosphamide
• Melphalan
• Cyclosporine
• Total lymphoid irradiation
• Rabbit anti-thymocyte globulin
• Mycophenolate Mofetil 250mg
• Solumedrol

Primary outcomes

• Incidence of Graft Versus Host Disease (GvHD) — 2 years after the last participant is enrolled.
  To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting

Countries

United States