UMIN-CTR Clinical Trial

Basic information
Public title	YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients
Acronym	MM1401:VRD/R trial
Scientific Title	YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients
Scientific Title:Acronym	MM1401:VRD/R trial
Region	Japan

Condition
Condition	multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of VRD thrapy as consolidation and Lenalidomide therapy as maintenance after autologous stem cell transplantation for patients with multiple meyloma less than 65-year-old
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	overall survival efficacy rate of VRD therapy completion rate of VRD therapy adverse event rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	bortezomib 1.3 mg/m2 s.c day1,8,15 lenalidomide 10 mg/body p.o. day1-21 dexamethasone 40 mg/body p.o. day1,8,15 repeat 4 times on every 28 days lenalidomide 10mg/body/day p.o. 21days every 28 days upto 2 years
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with symptomatic myeloma as criteria of International Myeloma Working Group (IMWG), and received autologous stem cell transplantation (ASCT) - high dose chemotherapy (HDT) 2. Patients with VGPR, PR or SD efficacy after ASCT 3. Patients with good general condition (ECOG Performance Status, PS 0-2) 4. Patients with mainteinedvisceral function a. SpO2 > 94 % b. 1) granulocyte count; 1000/microL 2) platelet count; 50000/microL c. renal function: independent from dialysis d. liver function 1) total bilirubin; 1.5xN 2) AST ; 2.5xN 3) ALT ; 2.5xN 5. Patients who can avoid pregnancy 6. Patients with informed concent 7. Patients who can presercve RevMate
Key exclusion criteria	1. Patients who have allergic history for bortezomib, lenalidomide, or dexamethasone. 2. Patients who diagnosed with malignancy of plasma cell other than myekoma. 3. Patient who cannot expect to survive more than 3 months. 4. Patients who have other active malignancy within past 5 years 5. Patients with positivity of HBs antigen, HCV antibody, or HIV antibody. 6. Patients with periferal neuropathy of CTCAE Grade 2-4. 7. Patients with severe active infection. 8. Patients with severe mental disturbance. 9. Patient with severe respiratory impairment. 10. Patients with interstitial pneumonia or pulmonary fiblosis. 11. Patients with severe cardiac dysfunction 12. Patients with uncontroled diabetes mellitus. 13. Patients who need dialysis. 14. Patients with severe liver dysfunction 15. Patients with pregnant or lactating 16. Patients who are considerded unsuitable for the trial by attending physician.
Target sample size	19

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuko Yamazaki
Organization	Yokohama City University Hospirtal
Division name	Clinical Laboratory Department
Zip code
Address	3-9 Fukuura Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	etsukoy@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Etsuko Yamazaki
Organization	Yokohama City University Hospital
Division name	Clinical Laboratory Department
Zip code
Address	3-9 Fukuura Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	etsukoy@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
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
Address
Tel
Email

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 06 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	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
Date of IRB	2014 Year 05 Month 15 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 03 Month 15 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 05 Month 22 Day
Last modified on	2019 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015956

Research Plan
Registered date	File name
2018/05/25	MM1401 VRDプロトコール_第1.6版_20170829作成_0907finalfix.doc

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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