UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009700 |
|---|---|
| Receipt number | R000011346 |
| Scientific Title | CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2018/05/27 14:03:15 |
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Basic information
Public title
CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Acronym
CBD induction and autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Scientific Title
CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Scientific Title:Acronym
CBD induction and autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Region
| Japan |
Condition
Condition
Newly diagnosed 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 CBD(cyclophosphamide, bortezomib and dexamethasone) following high dose therapy plus ASCT for patients with newly diagnosed multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
CR/nCR rate after CBD therapy
Key secondary outcomes
1)SCR,CR,nCR,VGPR and PR rate after CBD therapy
2)Overall survival(OS)
3)Progression free survival(PFS)
4)Duration of response
5)Incidence of adverse events
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
Induction therapy
Cyclophosphamide 300mg/m2 on days 1,8,15 and 22,orally
Bortezomib 1.3mg/m2 on days 1,8,15 and 22,subcutaneous injection
Dexamethasone 40mg/body on days 1,8,15 and 22,orally
4 cycles of cyclophosphamide,bortezomib and dexamethasone(CBD) regimen is repeated every 4 weeks.
Stem cell harvest
autologous peripheral stem cell is collected by mobilization with CPA(2g/m2 div d1,2) following G-CSF.
High dose chemotherapy and Autologous stem cell transplantation
L-PAM 200mg/m2 div(d-2),ASCT(d0)
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.multiple myeloma defined by IMWG criteria.
2.stage II-III of Durie and Slamon classification.
3.aged >15 and <65.
4.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
5.Main organ function is maintained
a.liver function:T-bil,AST and ALT < 2 times upper limit of normal standard
b.bone marrow function:Absolute neutrophil counts >1000/mm3,Platelet counts>100,000/mm3(Platelet transfusion before treatments is excluded),Hemoglobin>8.0g/dl(RCC transfusion before treatments is included)
c.cardiac function:EF >50%
d.pulmonary function:SaO2 >93%
e.renal function:Serum Creatinine <4mg/dl
6.No previous anti-myeloma therapy(Systemic steroid hormone is included).Bisphosphonate and denosumab are allowed.
7.voluntary written informed consent
Key exclusion criteria
1)History of allergic reactions to drugs contained in the protocol
2)Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 4
3)Uncontrolled or severe cardiovascular disease, including AMI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or cardiac amyloidosis
4)Acute severe infection requiring antibiotic therapy
5)HBs antigen,HCV antibody positive
6)Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin)
7)Pregnancy or breastfeeding
8)Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
9)Previous renal transplantation
10)Recurrent deep vein thrombosis or pulmonary embolism
11)Uncontrolled diabetes mellitus
12)Severe psychiatric disorders
13)Those who are considerd as inappropriate to register by attending physicians
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kojima |
Organization
Department of Medical Oncology, Ibaraki Prefectural Central Hospital
Division name
Assistant Director
Zip code
Address
6528 Koibuchi, Kasama-shi,Ibaraki 309-1793, Japan
TEL
0296-77-1121
h-kojima@chubyoin.pref.ibaraki.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kudo |
Organization
Hitachi General Hospital
Division name
Division of Hematology
Zip code
Address
2-1-1 Jonan-cho,Hitachi 317-0077,Japan
TEL
0294-23-1111
Homepage URL
daisuke.kudo.dv@hitachi.com
Sponsor or person
Institute
Ochanomizu blood study committee
Institute
Department
Personal name
Funding Source
Organization
NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
がん・感染症センター都立駒込病院(東京都)、(株)日立製作所日立総合病院(茨城県)、東京医科歯科大学(東京都)、水戸医療センター(茨城県)、茨城県立中央病院(茨城県)、埼玉医科大学(埼玉県)、埼玉医科大学国際医療センター(埼玉県)、都立墨東病院(東京都)、武蔵野赤十字病院(東京都)、横須賀共済病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、青梅市立総合病院(東京都)、独立行政法人国立印刷局東京病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 07 | 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
| 2012 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2018 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011346
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