UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009765 |
|---|---|
| Receipt number | R000011440 |
| Scientific Title | Bortezomib, cyclophosphamide plusd dexamethasone as induction treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2013/01/12 |
| Last modified on | 2017/01/16 09:24:06 |
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Basic information
Public title
Bortezomib, cyclophosphamide plusd dexamethasone as induction treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Acronym
VCD treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Scientific Title
Bortezomib, cyclophosphamide plusd dexamethasone as induction treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Scientific Title:Acronym
VCD treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma
Region
| Japan |
Condition
Condition
untreated 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 VCD as induction treatment prior to 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
sCR,CR and VGPR rate after 4 cycles of VCD treatment
Key secondary outcomes
1)overall response rate (sCR,CR,VGPR and PR) after 4 cycles of VCD
2)complete response rate (sCR and CR) after 4 cycles of VCD
3)completion rate of 4 cycles of VCD
4)total number of PBSC after PBSCH
5)completion rate of ASCT
6)complete response rate at 100 days after ASCT
7)incidence of adverse events
8)progression free survival duration
9)overall survival duration
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
VCD
bortezomib 1.3mg/m2 (iv or sc) on days 1,8,15 and 22
cyclophosphamide 300mg/m2 (po) on days 1,8,15 and 22
dexamethasone 20mg/body (po) on days 1,2,8,9,15,16,22 and 23
VCD treatment is repeated every 5 weeks.
PBSCH
peripheral stem cell is collected by mobilization with high-dose CPA or G-CSF.
for ASCT
L-PAM 200mg/m2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. multiple myeloma defined by IMWG criteria
2.untreated multiple myeloma
3.existence of measurable disease
4. aged >=20 and =<65
5. PS(ECOG) 0-2
6. The following standards are filled
1 )the neutrophil counts >= 1,000/mm3
2) the platelet counts >= 75,000/mm3
3) AST <= 2.5 times of a facilities standard value
4) ALT <= 2.5 times of a facilities standard value
5)T-bil <= 1.5 times of a facilities standard value
6)Cr <= 2.5 mg/dl
7)ischemic change, atrial fibrillation and ventricular arrhythmia to need treatment is neither found in echocardiography.
8) LV Ejection Fraction >= 50%
9)SpO2 >= 94%
10)Neither interstitial pneumonitis, pulmonary fibrosis, emphysema nor plueral effusion is recognized by computed tomography.
7. agree to contraception
8. voluntary written informed consent
Key exclusion criteria
1. severe renal damage: Ccr <30mL/min even after correction of dehydration and hypercalcemia
2.severe cardiac dysfunction: angina pectoris or acute myocardial infarction within 6 months of enrollment, congestive heart failure requiring medical treatment or arrhythmia requiring medical treatment.
3.severe respiratory dysfunction: SpO2 <= 93%, interstitial pneumonitis, chronic obstructive pulmonary disease, active pneumonia
4.infection
4-1HIV positive
4-2HBs antigen positive
4-3HBs antibody positive and/or HBc antibody positive and HBV-DNA positive
4-4HCV antibody positive
5.peripheral neuropathy > grade 2
6.Uncontrolled diabetes mellitus
7.others
7-1active double cancer
7-2pregnancy or breastfeeding
7-3doctor judged adequate to enroll the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rika Sakai |
Organization
Kanagawa Cancer Center
Division name
Department of Medical Oncology
Zip code
Address
2-3-2 Nakao Asahi-ku Yokohama City
TEL
045-520-2222
sakair@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Hattori |
Organization
Kanagawa Cancer Center
Division name
Department of Medical Oncology
Zip code
Address
2-3-2 Nakao Asahi-ku Yokohama City
TEL
045-520-2222
Homepage URL
hattori-ykh@umin.ac.jp
Sponsor or person
Institute
Kanagawa Cancer Center
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
None
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
横浜市立大学附属病院 （神奈川県）、横浜市立大学附属市民総合医療センター （神奈川県）、藤沢市民病院 （神奈川県）、横須賀市立市民病院 （神奈川県）、静岡赤十字病院 （神奈川県）、大和市立病院 （神奈川県）、済生会横浜市南部病院（神奈川県）、神奈川県立がんセンター（神奈川県）、横浜市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 12 | 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 | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 12 | Day |
Last modified on
| 2017 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011440
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
