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

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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 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


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

Value
https://center6.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