UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010258 |
|---|---|
| Receipt number | R000012007 |
| Scientific Title | Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2018/03/21 07:51:59 |
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Basic information
Public title
Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma
Acronym
SMUIM4-MM02
Scientific Title
Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma
Scientific Title:Acronym
SMUIM4-MM02
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of CD34 cells harvested
Toxicities
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
Uncontrolled
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/day) is added to the mobilization regimen on days 1, 8, and 15, in addition to high-dose cyclophosphamide (1.5 g/m2/day) given on day 1 and 2. 400 micrograms/m2/day of filgrastim (rhG-CSF) is provided subcutaneously after the nadir value of the absolute neutrophil count until harvest. At most three times of harvest is allowed if the total number of CD34 cells does not reach 1x106/kg.
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) Good performance status (0-2). Patients with bad performance status by the osteolytic lesions can be included.
2) Age more than 20 and less than 65 years old.
3) Main Organ function is maintained.
4) Those who are evaluated to be able to survive more than 3 months.
5) In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
Key exclusion criteria
1) Patients HIV-HBs-and HCV-positive.
2) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
3) Patients with a history of active malignancy.
4) Patients with severe psychiatric disorders.
5) Patients with pregnancy or lactation.
6) Those who are considered as inappropriate to register by attending physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sato |
Organization
Sapporo Medical University Hospital
Division name
Fourth Department of Internal Medicine
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo
TEL
011-611-2111
tsutomus@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Sato |
Organization
Sapporo Medical University Hospital
Division name
Fourth Department of Internal Medicine
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
tsutomus@sapmed.ac.jp
Sponsor or person
Institute
Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine
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
| 2013 | Year | 03 | Month | 18 | 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
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012007
