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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002922
Receipt No. R000003560
Scientific Title Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma
Date of disclosure of the study information 2009/12/21
Last modified on 2014/06/20

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Basic information
Public title Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma
Acronym Phase I study of weekly bortezomib for multiple myeloma
Scientific Title Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma
Scientific Title:Acronym Phase I study of weekly bortezomib for multiple myeloma
Region
Japan

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

Objectives
Narrative objectives1 To determine the safety, tolerability, and maximum tolerated dose of weekly bortezomib in Japanease patients with relapsed or refractory multiple myeloma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The dose-limiting toxicity of weekly bortezomib during the first cycle.
Key secondary outcomes Response rate, progression-free survival, overall survival, and adverse effects.

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 Phase I dose-escalation trial of bortezomib which involves two cohorts.
Cohort 1: bortezomib 1.3mg/m2
Cohort 2: bortezomib 1.6mg/m2
day 1,8,15,22
every five weeks, six cycles.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Relased or refractory multiple myeloma
2) Performans status 0-2
3) Normal function of major organ
4) Neuropathy: <=Grade 2 (CTCAE v3.0)
5) Written informed consent
6) Expected survival of >= 2 months
Key exclusion criteria 1) CNS involvement
2) History of severe drug allergy
3) Active infectious diseases
4) HBs antigen or HCV antibody or HIV antibody positive
5) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure
6) Interstitial pneumonitis
7) History of other active malignancy
8) Severe mental disorder
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kojima
Organization Ibaraki Prefectural Central Hospital
Division name Department of Chemotherapy
Zip code
Address 6528 Koibuchi, Kasama-city, Ibaraki prefecture
TEL 0296-77-1121
Email h-kojima@chubyoin.pref.ibaraki.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kojima
Organization Ibaraki Prefectural Central Hospital
Division name Department of Chemotherapy
Zip code
Address 6528 Koibuchi, Kasama-city, Ibaraki prefecture
TEL 0296-77-1121
Homepage URL
Email h-kojima@chubyoin.pref.ibaraki.jp

Sponsor
Institute NPO IB-HOPE
Institute
Department

Funding Source
Organization NPO IB-HOPE
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
2009 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 10 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

Management information
Registered date
2009 Year 12 Month 20 Day
Last modified on
2014 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003560

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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