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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004514
Receipt No. 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

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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
Email 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
Email im25@kochi-u.ac.jp

Sponsor
Institute Department of Hematology and Respiratory Medicine, Kochi University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005397

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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