UMIN-CTR Clinical Trial

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&#61619;2.05 mg/dL at time of high-dose therapy (HDT), liver dysfunction (e.g., a serum total bilirubin level&#61619;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 (&#61619;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
Last 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
Email	ntakezak@gmail.com

Public contact
1st 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
Email	bombmm1@jcrac.ac

Sponsor
Institute	National Hospital Organization Disaster Medical Center of Japan
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014817