UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007803 |
|---|---|
| Receipt number | R000009174 |
| Scientific Title | The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients. |
| Date of disclosure of the study information | 2012/04/21 |
| Last modified on | 2012/04/20 18:44:20 |
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Basic information
Public title
The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.
Acronym
The efficacy and safety of sPAD
Scientific Title
The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.
Scientific Title:Acronym
The efficacy and safety of sPAD
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy, safety, and the predictive factors of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
efficacy
Key secondary outcomes
safety
complete response rate
progression free survival
Blood concentration of bortezomib overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment protocol
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
According to the International Myeloma Working Group (IMWG) criteria, patients younger than 75 years with symptomatic MM were eligible for this trial.
Key exclusion criteria
The exclusion criteria were a serum creatinine level>2.05 mg/dL, 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 (>grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Takezako |
Organization
National Hospital Organization Disaster Medical Center
Division name
Hematology
Zip code
Address
3256 Midori Tachikawa Tokyo Japan
TEL
+81-42-526-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Takaezako |
Organization
National Hospital Organization Disaster Medical Center
Division name
Hematology
Zip code
Address
3256 Midori Tachikawa Tokyo Japan
TEL
+81-42-526-5511
Homepage URL
ntakezak@tdmc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
国立病院機構 災害医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009174
