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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016874
Receipt No. R000019585
Scientific Title Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
Date of disclosure of the study information 2015/03/23
Last modified on 2018/06/01

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Basic information
Public title Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
Acronym VRD-study
Scientific Title Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
Scientific Title:Acronym VRD-study
Region
Japan

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

Objectives
Narrative objectives1 Evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (Phase1)Safety of the VRD treatment
(Phase2)Response rate (VGPR + CR + sCR) after the sVRD therapy
Key secondary outcomes 1. Complete response rate(CR + sCR) after induction therapy.
2. Complete response rate(CR + sCR) after autologous stem cell transplantation
3. Complete response rate(CR + sCR) after consolidation therapy
4. Complete response rate(CR + sCR) after maintenance therapy
5. Treatment completion rate
6.3 years progression free survival duration
7.3 years survival duration
8. incidence of adverse events
9. Quantity of the stem cell

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.induction therapy
sVD 1cycle(every 21 days)
・Bortezomib 1.3mg/m2 sc day1,4,8,11
・Dexamethasone 20mg/body po day1,4,8,11

sVRD 4cycle(every 35 days)
・Bortezomib 1.3mg/m2 sc day1,8,15,22
・Lenalidomide 25mg/body po day1-21
・Dexamethasone 20mg/body po day1,8,15,22


2.Stem cell harvest and Autologous stem cell transplantation
Harvest
・Cyclophosphamide 1.5g/m2 div day1,2
・G-CSF sc day-5

Transplantation
・L-PAM 100mg/m2 div day-2,-1
・PBSCT day0


3.Consolidation therapy
Rd 4cycle(every 28 days)
・Lenalidomide 25mg/body po day1-21
・Dexamethasone 20mg/body po day1,8,15,22

4.maintenance therapy
R 24cycle(every 28 days)
・Lenalidomide 10mg/body po day1-21

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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.multiple myeloma defined by IMWG criteria.
2.aged from 20 to 65 years old.
3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
4.Main organ function is maintained
Absolute neutrophil counts >1000/mm
Platelet counts>75,000/mm3
T-bil < 3 times upper limit of normal standard
AST and ALT < 5 times upper limit of normal standard
Serum Creatinine <2mg/dl
EF >50%
SaO2 >93%
5. The patient who lives more than three months
6. The patient who can follow the RevMate
7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by having been obtained.
8.The HBc antibody and HBs antibody-positive patient is eligible for guidelines on conformity
Key exclusion criteria 1.non-secretary multiple myeloma or plasmacytoma or plasma cell leukemia, POEMS syndrom
2.HBs antigen,HCV antibody positive
3.HTLV-1 antibody, HIV antibody positive
4.Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
5.Patients with a history of active malignancy during the past 5 years.
6.Patients with psychiatric disorders such as schizophrenia etc.
7.Pregnant women, pre-menopausal women, and lactating women.
8.History of hypersensitivity to mannitol or boron.
9.dialysis patient
10.Patient of the vein thrombosis
11.Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
12.Those who are considered as inappropriate to register by attending physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Asaoku
Organization Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name Dept.Laboratory
Zip code
Address 1-9-6,Senda-machi,Naka-ku,Hiroshima
TEL 082-241-3111
Email blood@hiroshima-med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Itagaki
Organization Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name Dept.Hematology
Zip code
Address 1-9-6,Senda-machi,Naka-ku,Hiroshima
TEL 082-241-3111
Homepage URL
Email mitagaki@hiroshima-med.jrc.or.jp

Sponsor
Institute Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 03 Month 23 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2018 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019585

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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