UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201)
Acronym	CBD induction and ASCT for patients with newly diagnosed MM patients (NBMT-ASCT1201)
Scientific Title	Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201)
Scientific Title:Acronym	CBD induction and ASCT for patients with newly diagnosed MM patients (NBMT-ASCT1201)
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 on 3-year progression free survival and safety of incorporation novel agents (bortezomib and lenalidomide) into induction, consolidation and maintenance of high-dose therapy plus ASCT for patients with newly diagnosed multiple myeloma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3-year progression free survival
Key secondary outcomes	1.incidence of adverse events 2.incidence of therapy related mortality 3. pretreatment risk factors for prognosis 1) ISS 3, 2) serum LDH level, 3) cytogenetic abnormality, 4) t(4;14), t(14;16) or deletion of 17q proved by FISH analysis 4. treatment response 1) after CBD induction, 2) 12 weeks after ASCT 3)after consolidation, 4) after maintenance, and 5)at best response 5.time to progression 6. relapse free survival 7. overall survival 8. incidence of secondary primary malignancy 9.impact of response on prognosis 1) pre high-dose therapy, 2) post high dose therapy, 3) post consolidation

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A line of therapy composed of induction, autologous peripheral stem cell harvest (ASCH), high-dose chemotherapy (HDT)+autologous stem cell transplantation(ASCT), consolidation, and maintenance therapy are planned. After 3 courses of cyclophosphamide, bortezomib and dexamethasone (CBD) regimen is repeated every 4 weeks as an induction, autologous peripheral stem cell is collected by mobilization with G-CSF only. When expected number of CD34 positive stem cell is collected, high-dose melphalan (MEL200 mg/m2) is administered, followed by ASCT. After evaluating response of HDT+ASCT, 3 course of weekly bortezomib giving 4 doses every 6 weeks as a consolidation therapy, and 12 courses of lenalidomide 15 mg/day, d1-21 plus 20 mg/day of dexamethasone weekly 3 doses every 4 weeks as a maintenance are given.
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. symptomatic multiple myeloma defined by IMWG 3. no previous anti-myeloma chemotherapy 4. aged >20 and <65 5. PS(ECOG) 0-2 6. existence of measurable disease (one of the following) 1) serum M protein > 1g/dL 2) 24-hr urine M protein > 200 mg 7. voluntary written informed consent
Key exclusion criteria	1. multiple myeloma defined by IMWG criteria 2. symptomatic multiple myeloma defined by IMWG 3. no previous anti-myeloma chemotherapy 4. aged >20 and <65 5. PS(ECOG) 0-2 6. existence of measurable disease (one of the following) 1) serum M protein > 1g/dL 2) 24-hr urine M protein > 200 mg 7. voluntary written informed consent 1. plasma cell leukemia 2. severe renal damage: serum Cr > grade 3 even after correction of dehydration and hypercalcemia 3. severe cardiac dysfunction 1) LEVF < 50% 2) angina pectoris or acute myocardial infarction within 6 months of enrollment 3) congestive heart failure requiring medical treatment 4) arrhythmia requiring medical treatment. 4. severe respiratory dysfunction 1) SpO2 < 92% 2) interstitial pneumonitis 3) Chronic Obstructive Pulmonary Disease 4) active pneumonia 5. sever liver dysfunction 1) AST,ALT elevation > grade 2 (5xULN) 2) Total bilirubin elevation > grade 2 (3xULN) 6. infection 1) HIV positive 2) HBs antigen positive 7. peripheral neuropathy > grade 2 8. poor controlled diabetes mellitus even after treatment, having one or more of the following 1) HbA1c >8.0%, 2)fasten blood sugar > 160 mg/dL, 3) blood sugar after 2h of eating > 220 mg/dL 9. others 1) active opportunistic infection 2) active double cancer 3) doctor judged adequate to enroll the study
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Isamu Middle name Last name Sugiura
Organization	Toyohashi Municipal Hospital
Division name	Division of Hematology and Oncology
Zip code	441-8570
Address	50 Hachiken-nishi, Aotake-cho, Toyohashi, Japan #441-8570
TEL	0532-33-6111
Email	sugiura-isamu@toyohashi-mh.jp

Public contact
Name of contact person	1st name Isamu Middle name Last name Sugiura
Organization	Toyohashi Municipal Hospital
Division name	Division of Hematology and Oncology
Zip code	441-8570
Address	50 Hachiken-nishi, Aotake-cho, Toyohashi
TEL	0532-33-6111
Homepage URL
Email	sugiura-isamu@toyohashi-mh.jp

Sponsor
Institute	Toyohashi Municipal Hospital Division of Hematology and Oncology
Institute
Department

Funding Source
Organization	Nagoya BMT group
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	Clinical Research Supporting Office
Address	50 Hachiken-nishi, Aotake-cho, Toyohashi, Japan #441-8570
Tel	0532336111
Email	supporting-office@toyohashi-mh.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	豊橋市民病院（愛知県）、名古屋大学附属病院(愛知県)、愛知県がんセンター中央病院（愛知県）、江南厚生病院（愛知県）、安城更生病院（愛知県）、名古屋医療センター（愛知県）、名古屋第二赤十字病院（愛知県）、三重大学医学部付属病院（三重県）、藤田保健衛生大学附属病院（愛知県）、名古屋第一赤十字病院（愛知県）、浜松医科大学医学部附属病院（静岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 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	54
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	2012 Year 07 Month 23 Day
Date of IRB	2012 Year 05 Month 17 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2018 Year 12 Month 23 Day
Date of closure to data entry	2019 Year 02 Month 21 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 07 Month 11 Day
Last modified on	2022 Year 03 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009882