UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008399
Receipt No. R000009882
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)
Date of disclosure of the study information 2012/07/23
Last modified on 2020/01/15

* 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 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 No longer recruiting
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 11 Day
Last modified on
2020 Year 01 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.