UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002290 |
|---|---|
| Receipt number | R000002797 |
| Scientific Title | Specific immunotherapy for multiple myeloma using vaccine complex consisting of idiotype protein and monosodium urate crystals (phase I study) |
| Date of disclosure of the study information | 2009/08/04 |
| Last modified on | 2012/04/20 12:18:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Specific immunotherapy for multiple myeloma using vaccine complex consisting of idiotype protein and monosodium urate crystals (phase I study)
Acronym
Phase I study of vaccine complex consisting of idiotype protein and monosodium urate crystals
Scientific Title
Specific immunotherapy for multiple myeloma using vaccine complex consisting of idiotype protein and monosodium urate crystals (phase I study)
Scientific Title:Acronym
Phase I study of vaccine complex consisting of idiotype protein and monosodium urate crystals
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To certify the safety of cancer vaccine complex consisting of idiotype protein and monosodium urate crystals
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety during 8 weeks following the administration of vaccine complex idiotype protein and monosodium urate crystals
Key secondary outcomes
Antitumor effect on multiple myeloma
Induction of tumor-specific cytotoxic T cells
Safety of administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intradermal administration of vaccine complex idiotype protein and monosodium urate crystals
0.5 mg of idiotype protein per administration
Interventions/Control_2
1.0 mg of idiotype protein per administration
Interventions/Control_3
2.0 mg of idiotype protein per administration
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsutani |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Internal Medicine
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Tanaka |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Pharmacy
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Homepage URL
http://www.hosp.go.jp/~awara/kenkyu.html
nhoawara-secretary@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Awara Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Awara Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 03 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002797
