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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006490
Receipt No. R000007700
Scientific Title A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma
Date of disclosure of the study information 2011/10/20
Last modified on 2011/11/07

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Basic information
Public title A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma
Acronym subcutaneous injection of bortezomib, oral cyclophosphamide and dexamethasone (sVCD) therapy for myeloma
Scientific Title A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma
Scientific Title:Acronym subcutaneous injection of bortezomib, oral cyclophosphamide and dexamethasone (sVCD) therapy for myeloma
Region
Japan

Condition
Condition relapsed or refractory 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 sVCD therapy in relapsed or refractory myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The primary objective is to assess the efficacy of sVCD therapy for up to 6 cycles in patients with multiple myeloma who are relapsed or refractory to prior treatment.
Key secondary outcomes The soconday objective is to assess the safety of subcutaneous injection of bortezomib and sVCD therapy.

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 Bortezomib 1.3 mg/m2 on days 1, 8, 15 and 22, subcutaneous injection
Cyclophosphamide 300 mg/m2 on days 1, 8, 15 and 22, orally
Dexamethasone 40 mg daily on days 1, 8, 15 and 22, orally
Each cycle consist of 35-day treatment. Subject will receive up to 6 treatment cycles.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Male or female, aged > 20 years.
2. Give voluntary written informed consent before enrollment.
3. Relapse/refractory multiple myeloma in prior treatment.
4. At least 3 months life expectancy estimated at screening.
5. Possible to measure M protein in serum or urine.
6. Performance status 0-2.
7. Platelet counts > 75,000/mm3
8. Absolute neutrophil counts > 1500/mm3
9. AST and ALT < 2.5 times upper limit of normal standard
10. Bilirubin < 1.5 times of upper limit of normal standard
11. Serum Creatinine < 1.5 times of upper limit of normal standard
12. Ejection fraction is defined as > 50%
13. PaO2 > 60mmHg or SaO2 > 93%
14. Subject has a evidence of normal pulmonary finding by CT or X-Ray
Key exclusion criteria 1. History of allergic reactions to compounds containing mannitol, bortezomib, or boron.
2. Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol.
3. Active infection requiring treatment
4. Active hepatitis B or C.
5. Under treatment for a cancer other than multiple myeloma
6. Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function.
7. Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome.
8. Peripheral neuropathy > grade 2
9. Pregnant, lactation or potential
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tamura
Organization Fukuoka University Hospital
Division name Division of Medical Oncology, Hematology and Infectious Disease
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 81-92-801-2845
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Takamatsu
Organization Fukuoka University Hospital
Division name Division of Medical Oncology, Hematology and Infectious Disease
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 81-92-801-2845
Homepage URL http://www.chotsg.com/
Email yasushi@fukuoka-u.ac.jp

Sponsor
Institute Kyushu Hematology Organization for Treatment (KHOT)
Institute
Department

Funding Source
Organization Clinical Hematology Oncology Treatment Study Group (CHOT-SG)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2011 Year 10 Month 20 Day

Related information
URL releasing protocol http://www.chotsg.com/
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 Open public recruiting
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 05 Day
Last modified on
2011 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007700

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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