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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032970
Receipt No. R000037323
Official scientific title of the study 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 2018/07/27

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Basic information
Official scientific title of the study Multi-institutional observational research of therapeutic evaluation with minimal residual disease(MRD) after consolidation for multiple myeloma
Title of the study (Brief title) 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
20 years-old <=
Age-upper limit
66 years-old >=
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. Age from 20 to 65 at autologous stem cell transplantation.
3. No previous consolidation and maintenance therapy.
4. Patient who is planed Consolidation therapy.
5. PR and VGPR after autologous stem cell transplantation.
6. Patient who provided written consents for this study.
Key exclusion criteria 1. CR after autologous stem cell transplantation.
2. PD after autologous stem cell transplantation.
3. Patient who is judged to be medically unfit by physician.
Target sample size 22

Research contact person
Name of lead principal investigator Daisuke Kudo
Organization Tokyo-kita Medical Center
Division name Department of hematology
Address 4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL 03-5963-3311
Email daisukekud@jadecom.jp

Public contact
Name of contact person Daisuke Kudo
Organization Tokyo-kita Medical Center
Division name Department of hematology
Address 4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL 03-5963-3311
Homepage URL
Email daisukekud@jadecom.jp

Sponsor
Institute Ochanomizu Hematology Study Group
Institute
Department

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)

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)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 08 Day
Anticipated trial start date
2018 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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