UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004514 |
|---|---|
| Receipt number | R000005397 |
| Scientific Title | A phase II study of PAD therapy (bortezomib, doxorubicin, and dexamethasone) for relapsed or refractory multiple myeloma. |
| Date of disclosure of the study information | 2010/11/09 |
| Last modified on | 2014/02/24 10:00:31 |
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Basic information
Public title
A phase II study of PAD therapy (bortezomib, doxorubicin, and dexamethasone) for relapsed or refractory multiple myeloma.
Acronym
PAD therapy for advanced multiple myeloma
Scientific Title
A phase II study of PAD therapy (bortezomib, doxorubicin, and dexamethasone) for relapsed or refractory multiple myeloma.
Scientific Title:Acronym
PAD therapy for advanced multiple myeloma
Region
| Japan |
Condition
Condition
relapse or refractory multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of the combination therapy of bortezomib, doxorubicin, and dexamethasone (PAD) for relapsed or refractory multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate, safety
Key secondary outcomes
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
bortezomib 1.0mg/m2,iv, day1,4,8,11
doxorubicin 9mg/m2, iv, day1-4
dexamethasone 20mg,p.o. day1,2,4,5,8,9,11,12
every 3 weeks, total 6 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
2. Relapse/refractory multiple myeloma
3. Aged 20 to 80 years old
4. Performance status 0-3
5. Adequate organ function
ATL and AST of less than 5 times the ULN, total bilirubin of less than 3 times the ULN
6.serum creatinine less than 3 times the ULN
7. ECG: neither ischemic change nor arrhythmia requiring medical intervention
8. PaO2 (room air): at least 60 torr
9. Give voluntary written informed consent
before enrollment
Key exclusion criteria
1. Patients who have a serious active infection
2. Patients who have complication of active double cancer
3. Women who are or may be pregnant or are nursing
4. Patients with grade 2 or severer peripheral neuropathy or peripheral neurogenic pain (CTCAE v4.0)
5. Patient diagnosed with interstitial pneumonia in high resolution CT, and judged to improper to administer bortezomib
6. Other patients who are unfit for enrollment in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yokoyama |
Organization
Kochi University
Division name
Department of Hematology and Respiratory Medicine
Zip code
Address
Oko-cho Kohasu, Nankoku-shi, Kochi
TEL
088-880-2345
im25@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mizu Sakai |
Organization
Kochi univercity
Division name
Department of Hematology and Respiratory Medicine
Zip code
Address
Kohasu, Okocho, Nankoku city, Kochi
TEL
088-880-2345
Homepage URL
im25@kochi-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Respiratory Medicine, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Respiratory Medicine, Kochi University
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
| 2010 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
| 2010 | Year | 11 | Month | 08 | Day |
Last modified on
| 2014 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005397
| 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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