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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001210
Receipt No. 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

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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
Email 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
Email yasushi@fukuoka-u.ac.jp

Sponsor
Institute Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine, Fukuoka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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