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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010542
Receipt No. R000012054
Scientific Title Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma
Date of disclosure of the study information 2013/06/01
Last modified on 2018/04/28

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Basic information
Public title Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma
Acronym KHSG MM13
Scientific Title Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma
Scientific Title:Acronym KHSG MM13
Region
Japan

Condition
Condition Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Bortezomib containing induction, consolidation and maintenance therapy, and to investigate the efficacy of detection of minimal rsidual disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes CR rate 100 days after autologous PBSCT
Key secondary outcomes ORR after indecution therapy
ORR after PBSCH
ORR after 100 days after PBSCT
ORR after consolidation therapy
ORR during maiteinance therapy at 6, 12, 18, 24 months
2-years progression free survival
2 years overall survival
Time to pregression
Incidence of adverse events
mCR rate after induction, PBSCH, PBSCT, consolidation and maintenance therapy
Detection of Minimal residual disease in PBSCH products
Numer of CD34 cells harvested
Incidence of graft failure
Completion rate of maintenance therapy


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 Induction therapy (1st and 2nd courses)
Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1-3, 8-10 ,15-17, 22-24) every 28 days.

Induction therapy (2nd and 3rd courses)
Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1, 8 ,15, 22) every 28 days.

PBSC harvest
Cyclophosphamide 2.0g/m2 d.i.v (day 1 , 2) .

PBSCT with high dose chemotherapy
L-PAM 100mg/m2 d.i.v (day -3,-2).

Consolidation therapy (3 courses) Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1, 8 ,15, 22) every 28 days.

Maintenance therapy (uo to 2 years)Bortezomib 1.3mg/m2 s.c every 2 weeks.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1, Diagnosis of symptomatic multiple myeloma based on IMWG criteria. No prior therapy for MM.
3, Measurable M protein in serum or urin.
4, Age 20-65 years.
5, Performance status ECOG 0-2 (PS 3 possible only for osteolytic lesion).
6, Adequate organ functin.
7, Estimated life-expectancy greater than 3 months.
8, Sined, informed consent.
Key exclusion criteria 1, Non-secretary multiplemyeloma and plasma cell leukemia
2, HIV antibody positive, HBsAg positive, HBV-DNA positive, and HCV antibody positive.
3, Known hypersensivity to mannitol or boron.
4, Pregnant or breast-feeding women.
5, Active malignancy within last 5 years.
6, Serious psychiatric disordes or illness that could potentially interfere with the completion of treatment according to this protocol.
7, Active infection or serious co-morbid medical condition.
8, Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of chest CT.
9, History of sever hypersensivity to drugs.
10,Participants who are recoginized as inadaptable for this protocol.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Takaori-Kondo
Organization Kyoto University Hospital
Division name Department of Hematology/Oncology
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL 075-751-3150
Email atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kobayashi Masayuki
Organization Kyoto University Hospital
Division name Department of Hematology/Oncology
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL 075-751-3164
Homepage URL http://clisss.medical-edc.net/cybord/
Email mkobayas@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hematology Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
2013 Year 06 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2013 Year 04 Month 19 Day
Last modified on
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012054

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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