UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005960 |
|---|---|
| Receipt number | R000007042 |
| Scientific Title | Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma. |
| Date of disclosure of the study information | 2011/07/11 |
| Last modified on | 2011/07/11 11:15:48 |
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Basic information
Public title
Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.
Acronym
Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.
Scientific Title
Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.
Scientific Title:Acronym
Low-dose thalidomide treatment for patients with 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
The analysis of the saftey and effefacy of low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of adverse events and response rate
Key secondary outcomes
2-year progression free survival and 2-year overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) symptomatic myeloma according to the criteria ofIMWG.
(2)Relapsed and refractory myeloma after at least 1 treatment regimen.
(3)Patients who know they had multiple myeloma.
(4)Patients who are planned to be treated with thalidomide.
(5)Patients who had measurable M-protein.(IgG >= 1.0 g/dl, IgA, IgD >=0.5g/dl) or urin M-protein(>=0.2 g/day).
(6)>=20 years-old
(7)Patients with ECOG performance status:0-2 (Patients with PS 3 restricted by bone lesions are allowed to participate)
(8)Patients who are mached the below;
1)neutrophil count>=1,000/mm3
2)platelet count >=5x104/mm3
3)AST <=X2.5 of upper limit
4)ALT <=X2.5 of upper limit
5)Total bilirubin <=X1.5 of upper limit
6)SaO2 >= 90%(room air)
(9)No deep vein thrombosis or pulmonary embolism.
(10)Patients who have given written informed consent.
Key exclusion criteria
(1) patients with uncontrollable infection.
(2)patients with psychological diseases.
(3)female who can have children.
(4)patients who the doctor think unsuitable for this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Murakami |
Organization
Gunma Graduate School of Health Scineces
Division name
Department of Laboratory Sciences,
Zip code
Address
3-39-22 Showa-machi, Maebashi,
TEL
+81-27-220-8973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gunma Hematology Study Group |
Organization
Gunma Graduate School of Health Scineces
Division name
Gunma Graduate School of Health Scineces
Zip code
Address
3-39-22 Showa-machi, Maebashi,
TEL
+81-27-220-8973
Homepage URL
Sponsor or person
Institute
Gunma Hematological Disease Study Group
Institute
Department
Personal name
Funding Source
Organization
Fujimoto Co. LTD.
Organization
Division
Category of Funding Organization
Profit organization
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 | 07 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyse the safty and efficacy (response rate, 2-year progression-free survival, and 2-year over-all survival) in relapsed and refractory myeloma.
Management information
Registered date
| 2011 | Year | 07 | Month | 11 | Day |
Last modified on
| 2011 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007042
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