UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008399 |
|---|---|
| Receipt number | 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 | 2022/03/10 16:18:44 |
* 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
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
sugiura-isamu@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Division of Hematology and Oncology
Institute
Department
Personal name
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
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
Value
https://center6.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 |
