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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014038
Receipt No. R000015956
Scientific Title YCUMM-1401:Efficacy of VRD and Lenalidomide therapy after autologous stem cell transplantation for multiple myeloma patients
Date of disclosure of the study information 2014/06/01
Last modified on 2019/05/26

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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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