UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032970 |
|---|---|
| Receipt number | R000037323 |
| Scientific Title | Multi-institutional observational research of therapeutic evaluation with minimal residual disease(MRD) after consolidation for multiple myeloma |
| Date of disclosure of the study information | 2018/06/14 |
| Last modified on | 2020/06/24 18:50:25 |
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Basic information
Public title
Multi-institutional observational research of therapeutic evaluation with minimal residual disease(MRD) after consolidation for multiple myeloma
Acronym
OCHA-MRD
Scientific Title
Multi-institutional observational research of therapeutic evaluation with minimal residual disease(MRD) after consolidation for multiple myeloma
Scientific Title:Acronym
OCHA-MRD
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy of consolidation therapy after first and/or tandem autologous stem cell transplantation for patients with newly diagnosed multiple myeloma by evaluating MRD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The MRD negative rate by evaluating multiparameter flow cytometry(MFC) after consolidation therapy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Days 90 to 180 after first and/or tandem autologous stem cell transplantation for patients with newly diagnosed multiple myeloma.
2. No previous consolidation and maintenance therapy.
3. Patient who is planed Consolidation therapy.
4. PR after autologous stem cell transplantation.
5. Patient who provided written consents for this study.
Key exclusion criteria
Patient who is judged to be medically unfit by physician.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
daisukekud@jadecom.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
Homepage URL
daisukekud@jadecom.jp
Sponsor or person
Institute
Ochanomizu Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo-kita Medical Center
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
Tel
03-5963-3311
t-tanaka@tokyokita-jadecom.jp
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
東京北医療センター（東京都）、茨城県立中央病院（茨城県）、水戸医療センター（茨城県）、がん･感染症センター都立駒込病院（東京都）、東京医科歯科大学附属病院（東京都）、埼玉医科大学附属病院（埼玉県）、日立製作所日立総合病院（茨城県）、武蔵野赤十字病院（東京都）、横須賀共済病院（神奈川県） 、横浜市立みなと赤十字病院（神奈川県）、青梅市立総合病院（東京都）、花と森の東京病院（東京都）、埼玉医科大学国際医療センター（埼玉県）、都立墨東病院（東京都）、永寿総合病院（東京都）、聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 14 | 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
4
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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items in this study are listed as follows.
1. Patient backgrounds(Birthday, Age, Diagnosis, Clinical stage(ISS, DS), The day of diagnosis, The first day of induction therapy, The day of autologous stem cell transplantation, The first day of consolidation therapy
2. Clinical examination
1) complete blood cell count
2) TP, Alb, T-Bil, AST, ALT, LDH, ALP, GGT, BUN, Cre, Na, K, Cl, Ca, P, CRP, beta-2-microglobulin, immunoglobulin, serum free light chain, serum protein fraction, serum immunofixation
3) Urinary analysis(if only urine M protain positive): protein fraction, immunofixation, protein in 24 hour urine
3. Specialized medical examination
1) Bone marrow analysis
2) MRD
3) Radiologic examinations: CT, MRI, PET
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037323
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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