UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization	Tokyo-kita Medical Center
Address	4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
Tel	03-5963-3311
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037323