Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis

UMIN ID: UMIN000001962

Registered date:13/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 2009/07/01
• Target sample size: 22
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Nonmyeloablative allogeneic stem cell transplantation as a consolidation

Outcome(s)

• Primary Outcome: Cumulative incidence of nonrelapse mortality at 6 months
• Secondary Outcome: Engraftment rates, regimen-related toxicities, chimerism on peripheral blood, term to hematopoietic recovery, response rates, overall survival rates at 2 years, progression free survival at 2 years, nonrelapse mortality rates at 2 years, incidence of acute GVHD, and incidence of chronic GVHD

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1)Positive for HIV antibody, HBs antigen and/or HBe antigen (2)Pregnant or during breast feeding (3)Other active cancer (4)Active psychiatric disease (5)Active infection (6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (7)Cases that physicians judged as inappropriate

Related Information

• Primary Sponsor: Nagoya Blood and Marrow Transplantation Group
• Source(s) of Monetary Support: None