UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014038 |
|---|---|
| Receipt number | 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 09:33:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
etsukoy@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
