multiple myeloma
Conditions
Interventions
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 idio
Sponsors
National Hospital Organization Awara Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over aged 20 having multiple myeloma diagnosed with the criteria of SWOG Conditions of low tumor burden as follows Stage I by the criteria of Durie & Salmon PR or MR by the criteria of EBMT, IBMR, ABMTR and keeping plateau state Healthy volunteer who agreed to participate in writing
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety during 8 weeks following the administration of vaccine complex idiotype protein and monosodium urate crystals | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor effect on multiple myeloma Induction of tumor-specific cytotoxic T cells Safety of administration | — |
Countries
Japan
Contacts
Public ContactMitsuaki Tanaka
National Hospital Organization Awara Hospital Department of Pharmacy
Outcome results
None listed