UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017005
Receipt number R000019725
Scientific Title Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Date of disclosure of the study information 2015/04/20
Last modified on 2022/10/11 14:52:33

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Basic information

Public title

Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma

Acronym

NHOH-MMM study/H26-NHO(Hematology)-01

Scientific Title

Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma

Scientific Title:Acronym

NHOH-MMM study/H26-NHO(Hematology)-01

Region

Japan


Condition

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

o investigate the proportion of different genetic abnormalities detected by the multiplex ligation-dependent probe amplification (MLPA) method and clinical implication of its abnormality in symptomatic myeloma

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of different genetic abnormalities detected by the MLPA method

Key secondary outcomes

1. Complete response rate with the initial treatment of different genetic abnormalities detected by MLPA method
2. Progression free survival with the initial treatment of different genetic abnormalities detected by MLPA method
3. Overall survival with the initial treatment of different genetic abnormalities detected by MLPA method


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Untreated symptomatic myeloma more than 20 years at diagnosis
2.Patiets that the initial treatment is possible and survival is expected more than 6 months

Key exclusion criteria

1.Solitary plasmacytoma
2.Patients to use the insurance unapproved drugs to initial treatment
3.Patients that NHOMM study and MARBLE study are not registered

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kazutaka
Middle name
Last name Sunami

Organization

National Hospital Organization Okayama Medical Center

Division name

Department of Hematology

Zip code

701-1192

Address

1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan

TEL

086-294-9911

Email

kazusuna@pop12.odn.ne.jp


Public contact

Name of contact person

1st name Kazutaka
Middle name
Last name Sunami

Organization

National Hospital Organization Okayama Medical Center

Division name

Department of Hematology

Zip code

701-1192

Address

1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan

TEL

086-294-9911

Homepage URL


Email

kazusuna@pop12.odn.en.jp


Sponsor or person

Institute

Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization

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

National Hospital Organization

Address

2-5-1, Higashigaoka, Meguroku, Tokyo, 152-8621, Japan

Tel

03-5712-5075

Email

kenkyu2004@hosp.go.jp


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

2015 Year 04 Month 20 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

85

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Analysing

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

No longer recruiting

Date of protocol fixation

2015 Year 02 Month 20 Day

Date of IRB

2015 Year 04 Month 14 Day

Anticipated trial start date

2015 Year 04 Month 20 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Detection of the mutation of 1p32-p12, 1q21-q23, 5q31, chr.9, 12p13, 13q14, 14q32, 16q12-q23, 17p13 by MLPA method


Management information

Registered date

2015 Year 04 Month 01 Day

Last modified on

2022 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name