UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010169
Receipt number R000011879
Scientific Title Prospective observational study of newly diagnosed multiple myeloma in elderly patients
Date of disclosure of the study information 2013/03/06
Last modified on 2013/06/06 09:58:08

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Basic information

Public title

Prospective observational study of newly diagnosed multiple myeloma in elderly patients

Acronym

Prospective observational study of newly diagnosed multiple myeloma in elderly patients

Scientific Title

Prospective observational study of newly diagnosed multiple myeloma in elderly patients

Scientific Title:Acronym

Prospective observational study of newly diagnosed multiple myeloma in elderly patients

Region

Japan


Condition

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this observational study is to assess the relationship between patient outcomes, treatment regimens in newly diagnosed multiple myeloma aged 66 years and over.

Basic objectives2

Others

Basic objectives -Others

The objective of this observational study is to assess the relationship between patient outcomes, treatment regimens in newly diagnosed multiple myeloma aged 66 years and over.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

3 year survival rate

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


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

66 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group(IMWG).
2) Age >=66 years
3) A life expectancy of at least 3 months
4) Voluntary written informed consent

Key exclusion criteria

Plasma cell leukemia.

Target sample size

216


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiro Miyamoto

Organization

Kyushu University Hospital

Division name

Hematology and Oncology

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5230

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Fukuoka Blood and Marrow Transplantation Group (FBMTG)

Division name

EMM13 DC

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL


Homepage URL


Email

fbmtg@intmed1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Fukuoka Blood and Marrow Transplantation Group (FBMTG)

Institute

Department

Personal name



Funding Source

Organization

Janssen Pharmaceutical K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

2013 Year 03 Month 06 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

Open public recruiting

Date of protocol fixation

2013 Year 01 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patient characteristics
Treatment and progress summary


Management information

Registered date

2013 Year 03 Month 05 Day

Last modified on

2013 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name