UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006257 |
|---|---|
| Receipt number | R000007406 |
| Scientific Title | Pharmacokinetics and clinical outcomes of bortezomib in patients with newly diagnosed myeloma |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/03/29 09:26:10 |
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Basic information
Public title
Pharmacokinetics and clinical outcomes of bortezomib in patients with newly diagnosed myeloma
Acronym
Pharmacokinetics and clinical outcomes of bortezomib in patients with myeloma
Scientific Title
Pharmacokinetics and clinical outcomes of bortezomib in patients with newly diagnosed myeloma
Scientific Title:Acronym
Pharmacokinetics and clinical outcomes of bortezomib in patients with myeloma
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of effect of plasma concentration of bortezomib on efficacy or adverse events
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Response rate (VGPR + CR + sCR) to bortezomib + dexamethasone at the end of 2nd and 4th course of treatment
Key secondary outcomes
PFS, OS
Incidence of adverse events at the end of 2nd and 4th course of treatment. Adverse events are evaluated according to NCI CTCAE ver 4. Peripheral neuropathy is also evaluated based on the modified FACT/GOG-NTx scale
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
Patients with multiple myeloma currently visiting or admitting in Keio University Hospital and plan to receive weekly bortezomib + dexamethasone therapy. Those who do not receive prior chemotherapy except for dexamethasone or zoleedronic acid are included.
Key exclusion criteria
1) Patients without consent
2) Patients with PS 3 or worse
3) ANC < 1,000/cmm
4) AST > or = 3 x upper limit, ALT > or = 3 x upper limit, TB > or = 2 x upper limit
5) Interstitial pneumonia diagnosed by imaging, pulmonary function test, or blood examination. Patients with increased level of KL-6 without any other findings suspicious of interstitial pneumonia are included.
6) Peripheral neuropathy grade 3 or higher
7) Drug allergy against bortezomib or dexamethasone
8) Primary physician thinks it is inappropriate to enroll the patient
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University, School of Meidicine
Division name
Division of Hematology, Department of Medicine
Zip code
Address
35 Shinano-machi Shinjuku-ku Tokyo 160-8582, Japan
TEL
81-3353-1211
okamoto@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norisato Hashimoto |
Organization
Keio University, School of Meidicine
Division name
Division of Hematology, Department of Medicine
Zip code
Address
35 Shinano-machi Shinjuku-ku Tokyo 160-8582, Japan
TEL
81-3-3353-1211
Homepage URL
norisato@z3.keio.jp
Sponsor or person
Institute
Division of Hematology, Department of Medicine, Keio University, School of Meidicine
Institute
Department
Personal name
Funding Source
Organization
Division of Hematology, Department of Medicine, Keio University, School of Meidicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
Primary endpoint
Response rate (VGPR + CR + sCR) to bortezomib + dexamethasone at the end of 2nd and 4th course of treatment
Secondary endpoint
PFS, OS
Incidence of adverse events at the end of 2nd and 4th course of treatment. Adverse events are evaluated according to NCi CTV\CAE ver 4. Peripheral neuropathy is also evaluated based on the modified FACT/GOG-NTx scale
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2014 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007406
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
