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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003345
Receipt No. R000004057
Scientific Title Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (A multicenter clinical phase II trial, JMSG-0902)
Date of disclosure of the study information 2010/03/17
Last modified on 2015/10/02

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Basic information
Public title Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (A multicenter clinical phase II trial, JMSG-0902)
Acronym Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (JMSG-0902)
Scientific Title Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (A multicenter clinical phase II trial, JMSG-0902)
Scientific Title:Acronym Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (JMSG-0902)
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 plus dexamethasone therapy at days 1, 8, and 15 against elderly patients with relapsed or refractory multiple myeloma who have failed to prior therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Best response rate
Key secondary outcomes Safety
Completion rate
Progression free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eight cycles of bortezomib (1.3 mg/m2) + dexamethasone (20 mg/body) therapy on days 1, 8, and 15 in every 4 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
60 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG) before initial treatment with measureable M protein in serum(>=1g/dl) or urine (>=200 mg/day).
2) Relapsed or refractory myeloma after previous therapy (SD or PD). Patients who received dexamethasone can be included but bortezomib are excluded.
3) Patients without treatment for more than 4 weeks from the last therapy.
4) Age from 60 to 85 years old
5) Good performance status (0-2). Patients with PS 3 by the osteolytic lesions can be included.
6) Coexisting conditions are eligible as follows:
1. The neutrophil count >=1,000/mm3
2. The platelet count >=7.5X104/mm3
3. The Hb level >=8.0 g/dl
4. The serum AST value is less than 2.5 times from a facilities upper limit
5. The serum ALT value is less than 2.5 times from a facilities upper limit
6. The serum total bilirubin value is less than 2.0 times from a facilities upper limit
7. The serum creatinine value is less than 2.5 times from a facilities upper limit
8. The corrected calcium value <=12.5 mg/dl
9. The serum sodium value >=130 mEq/l
10. ECG neither ischemic change, Af, nor ventricular arrthymia requiring medical intervation
11. Cardiac ejection fraction >=50%
12. PaO2 >=60 mmHg or SpO2 >=93%
7) Written-informed consent has obtained.
Key exclusion criteria 1) Previous history of hypersensitivity for Bortezomib, dexamethasone, mannitol or boron
2) Non-secretary myeloma or plasma cell leukemia
3) Peripheral neuropathy (>=grade 2)
4) Positive for HIV antibody, HBs antigen, or HCV antibody. Patients with HTLV-1 antibody can be included.
5) Uncontrollable condition of liver dysfunction, renal dysfunction, heart failure, pulmonary failure, diabetes mellitus, hypertension, or infectious disease.
6) Active and progressive double cancer within 5 years (cured carcinoma in situ either the stomach, the large intestine, or the cervical uterus are excluded from double cancer).
7) Serious mental illness such as schizophrenia
8) Pregnant woman or possibility of getting pregnant, breast-feeding
9) Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of high-resolution chest CT, high levels of KL-6, SP-A, or SP-D
10) Others (inappropriate case)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Ozaki
Organization Tokushima Prefectural Central Hospital
Division name Department of Internal Medicine
Zip code
Address 1-10-3 Kuramoto,Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Advanced Clinical Research Organization
Division name Headoffice
Zip code
Address 4F Hoei Fuchu Bulding,2-10-3 Kotobukicho,Fuchu-shi,Tokyo JAPAN 183-0056
TEL 042-352-7676
Homepage URL
Email jmsg-0902jimukyoku@npo-acro.jp

Sponsor
Institute Japan myeloma study 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 YES
Study ID_1 JMSG-0902
Org. issuing International ID_1 Japan myeloma study group
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 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2010 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 17 Day
Last modified on
2015 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004057

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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