UMIN-CTR Clinical Trial

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
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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
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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
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Research case data
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