UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013912
Receipt number R000016222
Scientific Title Phase II study of bortezomib maintenance therapy for multiple myeloma patients
Date of disclosure of the study information 2014/05/09
Last modified on 2019/04/25 13:47:44

* 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

Phase II study of bortezomib maintenance therapy for multiple myeloma patients

Acronym

BOMB-after

Scientific Title

Phase II study of bortezomib maintenance therapy for multiple myeloma patients

Scientific Title:Acronym

BOMB-after

Region

Japan


Condition

Condition

Multiple Myeloma

Classification by specialty

Medicine in general Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of 2 year-maintenance therapy after ASCTin younger Japanese patients with MM

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

TTP after ASCT

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bortezomib (1.3 mg/m2) was administered by S.C. biweekly.

Interventions/Control_2

no treatment

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

According to the International Myeloma Working Group (IMWG) criteria20, patients younger than 65 years with symptomatic MM were eligible for this trial.

Key exclusion criteria

The exclusion criteria were a serum creatinine level&#61619;2.05 mg/dL at time of high-dose therapy (HDT), liver dysfunction (e.g., a serum total bilirubin level&#61619;2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (&#61619;grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer

Target sample size

96


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Takezako

Organization

National Hospital Organization Disaster Medical Center of Japan

Division name

Department of Hematology

Zip code


Address

3256 Midori-cho, Tachikawa-shi

TEL

024-526-5511

Email

ntakezak@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yasuharu Sasaki

Organization

JCRAC

Division name

Data Center

Zip code


Address

1-21-3 Toyama Shinjyuku Tokyo

TEL

03-5287-5121

Homepage URL


Email

bombmm1@jcrac.ac


Sponsor or person

Institute

National Hospital Organization Disaster Medical Center of Japan

Institute

Department

Personal name



Funding Source

Organization

janssen

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

2014 Year 05 Month 09 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

2013 Year 07 Month 25 Day

Date of IRB

2014 Year 04 Month 19 Day

Anticipated trial start date

2014 Year 05 Month 12 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 05 Month 09 Day

Last modified on

2019 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name