UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001210 |
|---|---|
| Receipt number | R000001475 |
| Scientific Title | Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study |
| Date of disclosure of the study information | 2008/06/26 |
| Last modified on | 2018/05/14 16:34:41 |
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Basic information
Public title
Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study
Acronym
iPAd theapy for multiple myeloma
Scientific Title
Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study
Scientific Title:Acronym
iPAd theapy for multiple myeloma
Region
| Japan |
Condition
Condition
Relapse/Refractory Multiple Myeloma
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety for the treatment of bortezomib, adriamycin plus intermediate-dose dexamethasone (iPAD) for relapsed or refractory multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Complete remission rate
Key secondary outcomes
PR rate
PFS
Time to response
OS
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 1.0 mg/m2 or 1.3 mg/m2 on
Days 1, 4, 8, and 11, IV
Doxorubicin 9 mg/m2 on Day 1 to 4 IV Dexamethasone 20 mg daily on Days 1 to 2, 4 to 5, 8 to 9, and 11 to 12, orally
Each cycle consist of 21-day treatment.
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.Relapse/refractory multiple myeloma
2.Possible to measure M protein in serum or urine
3.Performance status 0-2
4.Age between 20 and 80 years
5.Adequate organ function
6.Give voluntary written informed consent before enrollment
Key exclusion criteria
1.Use of bortezomib in the previous treatment.
2.History of allergic reactions to compounds containing mannitol, bortezomib, or boron
3.Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol.
4.Active infection requiring treatment
5.Active hepatitis B or C.
6.Under treatment for a cancer other than multiple myeloma
7.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function.
8.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome.
9.Peripheral neuropathy> grade 2
10.Pregnant, lactation or potential
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KazuoTamura |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
ktamura@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takamatsu |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
yasushi@fukuoka-u.ac.jp
Sponsor or person
Institute
Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Non profit organization Clinical Hematology Oncology Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001475
