UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001347 |
|---|---|
| Receipt number | R000001636 |
| Scientific Title | A clinical phase I study to define recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2013/04/02 22:28:11 |
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Basic information
Public title
A clinical phase I study to define recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma
Acronym
A phase I study of combination with cyclophosphamide, bortezomib and dexamethasone for relapsed and refractory multiple myeloma
Scientific Title
A clinical phase I study to define recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma
Scientific Title:Acronym
A phase I study of combination with cyclophosphamide, bortezomib and dexamethasone for relapsed and refractory multiple myeloma
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To define recommended dose fo cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
definition of recommended dose for cyclophosphamide in C-BD regimen
Key secondary outcomes
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
1. Patients receive three 3-week treatment cycles with bortezomib(BTZ) 1.3 mg/m2 on days 1,4,8,11 combination with dexamethasone(DEX) 20 mg/m2 intravenously on days 1,2,4,5,8,9,11,12. 2. In addition, patients receive cyclophosphamide(CY)intravenously on days 1,8 at either 300, 400, 500 mg/m2 to define the recommended dose. Start dose are 300 mg/m2 and dose up with 3-cohort.
3.DLT is defined using CTCAEver3 as
1) either neutropenia (<500/mm3) or thrompocyotopenia(<25,000/mm3)
2) >=grade 3 non-hematologic toxicity except peripheral neuropathy(PN)
3) grade 3 PN which continues for more than 5 days and grade 4 PN.
4) delay to start second course for any adverse events for more than 3 weeks.
4. If no DLT in the first course, patients receive two additional courses keeping the starting dose of CY to evaluate 3 courses of combination chemotherapy for further clinical study.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibilty criteria includes;
1.relapsed, refractory multiple myeloma
2. age 20-69
3. PS(ECOG): 0 and 1
4. No chemotherapy for more than 3 weeks since previous chetherapy.
5. A total WBC count >=3000/mm3, absolute neutrophil count >= 1500/mm3, Platelete count >=75000/mm3.
6. ALT of less than 2.5 times the ULN, TB .of less than 1.5 times the ULN.
7. serum creatinine less than 2 times the ULN
8. Left Ventricular Ejection Fraction >= 50%
9. SaO2 >=92%
10. Having measurable diseases of serum M-protein >=1g/dL or 24hrs urine M-protein >=200 mg
11. Giving written informed consent before entering the study
Key exclusion criteria
Exclusion criteria includes;
1.Cardiovascular diseases
1) Angina pectoris, and acute myocardial infarction within recent 6 months
2) congestive heart failure which requires treatment
3) arrhythmia which requires treatment
2. Respiratory diseases
1) interstitial pneumonitis
2)COPD
3)infections more than twice which in a previous year
3. infectious diseases
1) HIV infection
2) HBsAg positive
3) HBsAb and/or HBcAb posive
4) anti HCV positive
4. neuropathy
1) peripheral neuropathy grade>= 2
2) neural pain due to peripheral neuropaty
5. diabetes mellitus
6. allergy to cyclophosphamide
7.active double cancer
8.subjects who are not likely to participate in the study for any reason in the opinion of the investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Sugiura |
Organization
Toyohashi Municipal Hospital
Division name
Divsion of Hematology/Oncology
Zip code
Address
50 Hakkennishi, Aotake-cho, Toyohashi
TEL
0532-33-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Sugiura |
Organization
Toyohashi Municipal Hospital
Division name
Divsion of Hematology/Oncology
Zip code
Address
TEL
Homepage URL
http://www.c-shot.or.jp/
isugiura-sgr@umin.ac.jp
Sponsor or person
Institute
Center for Supporting Hematology-Oncology Trial(C-SHOT)
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
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
| 2008 | Year | 09 | Month | 01 | 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
| 2008 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 01 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001636
