Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

UMIN ID: C000000168

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Multiple myeloma that refractory or relapsed for autologous stem cell transplantation
• Date of first enrollment: 2004/08/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Non-myeloablative conditioning of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors

Outcome(s)

• Primary Outcome: 1)Therapy related mortality at 100 days after hematopoietic stem cell transplantation 2)Engraftment rate at 100 days after hematopoietic stem cell transplantation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Insulin dependent diabetes mellitus 2) Uncontrolable HT 3) Unstable angina, heart failure, or myocardial infarction 4) interstitial pneumonia or pulmonary fibrosis 5) positive HBs antigen 6) seropositive to HCV 7) seropositive to HIV 8) Severe infections 9)double cancer 10)Pregnant women 11) Sever mental disease 12) Patients inappropriate for transplantation with reasons other than above.

Related Information

• Primary Sponsor: Nagoya BMT Group
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): C-SHOT0403