UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002922 |
|---|---|
| Receipt number | 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 16:53:56 |
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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
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
h-kojima@chubyoin.pref.ibaraki.jp
Sponsor or person
Institute
NPO IB-HOPE
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
