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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007880
Receipt No. R000009276
Scientific Title To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Date of disclosure of the study information 2012/05/02
Last modified on 2016/12/03

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Basic information
Public title To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Acronym Kanshinetsu MMG-002
Scientific Title To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Scientific Title:Acronym Kanshinetsu MMG-002
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy and safety of bortezomib-based induction therapy followed by bortezomib maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival
Key secondary outcomes Incidents of adverse events during 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 Bortezomib-based induction therapy followed by bortezomib maintenance therapy (1.3mg/m2) in every 2 weeks for one year.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
2. Measureable M protein in serum or urine.
3. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
4. Age more than 20 years old.
5. Main Organ function is maintained
6. Those who are evaluated to be able to survive more than 3 months.
7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
Key exclusion criteria 1. Non-secretory MM and plasmacell leukemia.
2. Patients HIV-HBs-and HCV-positive
3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
4. Patients with a history of active malignancy during the past 5 years.
5. Patients with psychiatric disorders such as schizophrenia etc.
6. History of hypersensitivity to mannitol or boron.
7. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary
8. Those who are considered as inappropriate to register by attending physicians.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Murakami
Organization Gunma Graduate School of Health Scineces
Division name Department of Laboratory Sciences,
Zip code
Address 3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Isoda
Organization NHO National Nishigunma Hospital
Division name Department of Internal Medicine
Zip code
Address 2854 Kanai, Shibukawa-shi, Gunma
TEL 0279-23-3030
Homepage URL
Email

Sponsor
Institute Kanshinetsu Multiple Myeloma Group
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
2012 Year 05 Month 02 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
2012 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 02 Day
Last modified on
2016 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009276

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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