UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014197 |
|---|---|
| Receipt number | R000015992 |
| Scientific Title | Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/04/28 12:18:44 |
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Basic information
Public title
Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Acronym
KHSG MM14
Scientific Title
Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Scientific Title:Acronym
KHSG MM14
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analyzing and measuring minimal residual disease (MRD), serum concentration of cytokines and QoL score during lenalidomide monotherapy as maintenace following bortezomib containing induction therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The colleration between the clinical efficacy of lenalidomide for multiple myeloma and the MRD, the serum concentration of cytokines, and QoL socre
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation
Key exclusion criteria
patient who is not suitable for taking part in this study from the sight of the physician in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Takaori-Kondo |
Organization
Kyoto university hospital
Division name
Department of Hematology and Oncology
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL
075-751-3150
atakaori@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Kitano |
Organization
Kyoto university hospital
Division name
Department of Hematology and Oncology
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL
075-751-3152
Homepage URL
tkitano@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine, Kyoto university, Department of Hematology and Oncology
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
| 2014 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
The evaluation of MRD, the concentration of serum cytokines and QoL score during Lenalidomide maintenance in newly diagnosed mutiple myeloma patients who are ineligible for autologous transplantation
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015992
