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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009668
Receipt No. R000011341
Scientific Title Phase I study of a B-HDM regimen for elderly multiple myeloma patients
Date of disclosure of the study information 2013/01/01
Last modified on 2019/04/25

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Basic information
Public title Phase I study of a B-HDM regimen for elderly multiple myeloma patients
Acronym B-HDM regimen
Scientific Title Phase I study of a B-HDM regimen for elderly multiple myeloma patients
Scientific Title:Acronym B-HDM regimen
Region
Japan

Condition
Condition Multiple Myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety of B-HDM before ASCT in elderly Japanese patients with MM
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes safty
Key secondary outcomes efficacy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 B-HDM
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
65 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria According to the International Myeloma Working Group (IMWG) criteria20, patients younger than 70 years with symptomatic MM were eligible for this trial.
Key exclusion criteria The exclusion criteria were a serum creatinine level<2.05 mg/dL at time of high-dose therapy (HDT), liver dysfunction (e.g., a serum total bilirubin level<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 12

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 042-526-5511
Email ntakezak@gmail.com

Public contact
Name of contact person
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 042-526-5511
Homepage URL
Email ntakezak@tdmc.hosp.go.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center of Japan
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 01 Month 01 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
2012 Year 12 Month 20 Day
Date of IRB
2012 Year 12 Month 22 Day
Anticipated trial start date
2013 Year 01 Month 04 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
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 30 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011341

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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