Safety of intradermal administration of monosodium urate crystals as a carrier of idiotype cancer vaccine

UMIN ID: UMIN000001624

Registered date:07/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: multiple myeloma
• Date of first enrollment: 2007/06/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intradermal administration of monosodium urate crystals 2.0 mcg of monosodium urate crystals per administration
20 mcg of monosodium urate crystals per administration
200 mcg of monosodium urate crystals per administration
2.0 mg of monosodium urate crystals per administration

Outcome(s)

• Primary Outcome: Safetiness during three weeks following the administration of monosodium urate crystals
• Secondary Outcome: Serum level of inflammatory cytokines Decndritic cell count in the peripheral blood

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Adolecents having major organ injury indicated by elevated level of serum creatinine, total bilirubin or ALT , or having symptomatic congestive heart failure 2) Patients suffering from gout 3) Patients with any of active autoimmune disease 4) Patients with any of active infectious disease 5) Women on (possible) pregnancy or lactation 6) Adolecents 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