UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003345 |
|---|---|
| Receipt number | 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 08:45:32 |
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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
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
jmsg-0902jimukyoku@npo-acro.jp
Sponsor or person
Institute
Japan myeloma study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004057
