UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012700 |
|---|---|
| Receipt number | R000014817 |
| Scientific Title | Phase II study of a BD-HDM regimen for multiple myeloma patients |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2019/04/25 13:50:13 |
* 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
Phase II study of a BD-HDM regimen for multiple myeloma patients
Acronym
Bomb-MM01
Scientific Title
Phase II study of a BD-HDM regimen for multiple myeloma patients
Scientific Title:Acronym
Bomb-MM01
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of BD-HDM before ASCTin younger Japanese patients with MM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To investigate the safety of BD-HDM before ASCTin younger Japanese patients with MM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bortezomib (1 mg/m2) was administered intravenously on days -6, -3, 1, and 4. Dexamethazone (20 mg) was administered orally on days -6,-5, -3, -2, 1, 2, 4, and 5. Melphalan was administered intravenously at a dose of 200 mg/m2 on day -2. Peripheral blood stem cells 106 CD34+ cells/kg) were infused on day 0
Interventions/Control_2
High dose chemotherapy and PBSCT:L-PAM 200mg/m2 div (day-2). Peripheral blood stem cells 106 CD34+ cells/kg) were infused on day 0
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
According to the International Myeloma Working Group (IMWG) criteria20, patients younger than 65 years with symptomatic MM were eligible for this trial.
Key exclusion criteria
The exclusion criteria were a serum creatinine level2.05 mg/dL at time of high-dose therapy (HDT), liver dysfunction (e.g., a serum total bilirubin level2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Takezako |
Organization
National Hospital Organization Disaster Medical Center of Japan
Division name
Department of Hematology
Zip code
Address
3256 Midori-cho, Tachikawa-shi
TEL
042-526-5511
ntakezak@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Sasaki |
Organization
JCRAC
Division name
Data Center
Zip code
Address
1-21-3 Toyama Shinjyuku Tokyo
TEL
03-5287-5121
Homepage URL
bombmm1@jcrac.ac
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center of Japan
Institute
Department
Personal name
Funding Source
Organization
janssen
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014817
