Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)

UMIN ID: C000000178

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: multiple myeloma
• Date of first enrollment: 2004/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Therapy is composed of the following three steps of therapy. 1. induction chemotherapy(3 courses of C-VAD regimen) 2. peripheral stem cell collection after high dose cyclophosphamide 3. autologous peripheral stem cell transplantation after high dose melphalan

Outcome(s)

• Primary Outcome: Response rate after 90 days from the transplantation

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Severe renal dysfunction 2. Severe cardiovascular dysfunction 3. Active infections 4. Active opportunistic infections 5. Active double cancers 6. Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason

Related Information

• Primary Sponsor: Center for Supporting Hematology-Oncology Trials (C-SHOT)
• Secondary Sponsor: Nagoya Muliple Myeloma Collaborated Group
• Source(s) of Monetary Support: Nagoya BMT group