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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003043
Receipt No. R000003684
Scientific Title A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Date of disclosure of the study information 2010/01/25
Last modified on 2012/01/26

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Basic information
Public title A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Acronym A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Scientific Title A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Scientific Title:Acronym A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of bortezomib as maintenance therapy for multiple myeloma after autologous stem cell transplantation comparing with thalidomide therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate 1 year after stem cell transplantation
Key secondary outcomes Response rate 2 and 3 year after stem cell transplantation.
Progression free survival, overall survival, and adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bortezomib 1.3 mg/m2 iv., day 1,8,15,and 22. 6 courses in 35-day cycle.
Interventions/Control_2 Thalidomide 100 mg/day po. for 180days.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with multiple myeloma who have recieved autologous hematopoietic stem cell transplantation for the first time within 3 months. (Including patients who will recieved autologous hematopoietic stem cell transplantation.)
2. Meet the guidelines for administration of Bortezomib at the start of the study treatment.
3. Clinical data at disease onset and before transplantation can be obtained.
4. Maintenance therapy can be started by 4 months after transplantation.
5. Written-informed consent has obtained.
Key exclusion criteria 1. Allergy for thalidomide, Bortezomib, mannitol,and boron.
2. A woman during pregnancy or potential pregnancy
3. Patients unable to comply with safety management procedures of thalidomide.
4. Patients who cannot stop drugs or therapy restricted in this trial.
5. Patients who are recognized as inadaptable for this trial.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kurokawa
Organization University of Tokyo Hospital
Division name Hematology and Oncology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo Hospital
Division name Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute University of Tokyo Hospital,
Department of Hematology and Oncology
Institute
Department

Funding Source
Organization None
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 01 Month 25 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
2009 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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 01 Month 15 Day
Last modified on
2012 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003684

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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