Specific immunotherapy for multiple myeloma using vaccine complex consisting of idiotype protein and monosodium urate crystals (phase I study)

UMIN ID: UMIN000002290

Registered date:04/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: multiple myeloma
• Date of first enrollment: 2008/08/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intradermal administration of vaccine complex idiotype protein and monosodium urate crystals 0.5 mg of idiotype protein per administration
1.0 mg of idiotype protein per administration
2.0 mg of idiotype protein per administration

Outcome(s)

• Primary Outcome: Safety during 8 weeks following the administration of vaccine complex idiotype protein and monosodium urate crystals
• Secondary Outcome: Antitumor effect on multiple myeloma Induction of tumor-specific cytotoxic T cells Safety of administration

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Adolescents having major organ injury indicated by elevated level of serum creatinine, total bilirubin or ALT , or having symptomatic congestive heart failure Patients suffering from gout Patients with any of active autoimmune disease Patients with any of active infectious disease Women on (possible) pregnancy or lactation Adolescents judged inadequate by doctor in charge of the patient or the study

Related Information

• Primary Sponsor: National Hospital Organization Awara Hospital
• Source(s) of Monetary Support: National Hospital Organization Awara Hospital