UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006490 |
|---|---|
| Receipt number | 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 15:22:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
yasushi@fukuoka-u.ac.jp
Sponsor or person
Institute
Kyushu Hematology Organization for Treatment (KHOT)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
