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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001347
Receipt No. 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

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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
Email

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/
Email isugiura-sgr@umin.ac.jp

Sponsor
Institute Center for Supporting Hematology-Oncology Trial(C-SHOT)
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001636

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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