UMIN-CTR Clinical Trial

Basic information
Public title	A phase 2 study of bortezomib, lenalidomide and dexamethasone (VRD) following auto-PBSCT for untreated multiple myeloma.
Acronym	OCHA-VRD
Scientific Title	A phase 2 study of bortezomib, lenalidomide and dexamethasone (VRD) following auto-PBSCT for untreated multiple myeloma.
Scientific Title:Acronym	OCHA-VRD
Region	Japan

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

Objectives
Narrative objectives1	To clarify the efficacy and safety of VRD (Bortezomib, lenalidomide, dexamethasone) therapy following mobilization using bortezomib, low-dose cyclophosphamide, G-CSF and high-dose melphalan plus autologous peripheral blood stem cell transplantation(auto-PBSCT) for untreated multiple myeloma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CR/nCR rate for VRD therapy
Key secondary outcomes	Overall survival (OS); Progression free survival (PFS); Overall response rate for VRD therapy; Overall response rate at 90 days after ASCT; Best response through the trial; Adverse event; CD34+ cell count after aphereses; Rate of reaching CD34+ cell count >= 2*10^6/kg; Therapy related quality of life.

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. VRD (Bortezomib 1.3mg/m2 s.c.;d1,4,8,11, lenalidomide 25mg/day p.o.;d1-14, dexamethasone 40mg/day;d1,4,8,11) therapy as induction therapy. 2. Mobilization using bortezomib,low-dose cyclophosphamide and G-CSF(cyclophosphamide 1g/m2 div;d1, bortezomib 1.3mg/m2 s.c.;d4,7, G-CSF;day4-) 3. High-dose melphalan plus auto-PBSCT(L-PAM 200mg/m2 div;d -2)
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.Patient in symptomatic multiple myeloma or symptomatic nonsecretary myeloma according to IMWG criteria(2011). 2.Patient who has measurable disease. 3.Age >= 20 and <= 65 at time of registration. 4.ECOG-Performance Status(PS)is 0-2. 5.No interstitial pulmonary disorder is detected by X-ray or CT. 6.Patent who meets the following criteria; a) Liver function:T-Bil <= 1.5*ULN, AST or ALT <= 2.5*ULN; b) Bone marrow function ANC >= 1000/uL, Platelet >= 7.5*10^4/uL; c) Heart function: EF >= 55%; d) Pulmonary function: SpO2 >= 93%; e) Renal function: Ccr >= 30ml/min(Cockroft-Gault). 7.Untreated multiple myeloma. 8.Patient who can agree the registration for RevMate and keep its administrative procedure. 9.Patient who provided written consents for this study.
Key exclusion criteria	1.Patient who has hypersensitivity to the study drugs. 2.Patient who has Grade >= 2 peripheral neuropathy (NCI CTCAE ver.4). 3.Patient who has sufficient heart disorders. 4.Uncontrolled active infection. 5.HBs antigen positive and/or HCV positive. 6.Active advanced-stage cancer. 7.Female patient who is pregnant and/or breastfeeding. 8.Active gastrointestinal bleeding. 9.Past history of renal transplantation. 10.Past history of pulmonary embolism, myocardial infarction and cerebral infarction. 11.Past history of deep vein thrombosis, administration of anticoagulants and/or antiplatelet drugs. 12.Uncontrolled diabetes mellitus. 13.Serious psychiatric illness 14.Patient who is judged to be medically unfit by his/her physician.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Ikuyo Middle name O Last name Tsutsumi
Organization	National Hospital Organization Mito Medical Center
Division name	Department of Hematology
Zip code	311-3193
Address	280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL	029-240-7711
Email	ikuyo.ota@gmail.com

Public contact
Name of contact person	1st name Ikuyo Middle name O Last name Tsutsumi
Organization	National Hospital Organization Mito Medical Center
Division name	Department of Hematology
Zip code	311-3193
Address	280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL	029-240-7711
Homepage URL
Email	ikuyo.ota@gmail.com

Sponsor
Institute	Ochanomizu Hematology Study Group
Institute
Department

Funding Source
Organization	NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Mito Medical Center IRB
Address	280, Sakuranosato, Ibarakimachi, Higashiibarakigun, Ibaraki, Japan
Tel	029-240-7711
Email	mito.kenkyu.g@mn.hosp.go.jp

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	2017 Year 03 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	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 08 Day
Date of IRB	2017 Year 02 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 27 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030235