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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002290
Receipt No. 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

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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
Email

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
Email nhoawara-secretary@umin.ac.jp

Sponsor
Institute National Hospital Organization Awara Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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