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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012789
Receipt No. R000014940
Scientific Title Evaluation of safety of the combination of high dose melphalan with bortezomib as conditioning regimen for autologous stem cell transplant for multiple myeloma: a clinical phase I study
Date of disclosure of the study information 2014/01/08
Last modified on 2016/02/15

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Basic information
Public title Evaluation of safety of the combination of high dose melphalan with bortezomib as conditioning regimen for autologous stem cell transplant for multiple myeloma: a clinical phase I study
Acronym Keio Mel-Bor Phase I
Scientific Title Evaluation of safety of the combination of high dose melphalan with bortezomib as conditioning regimen for autologous stem cell transplant for multiple myeloma: a clinical phase I study
Scientific Title:Acronym Keio Mel-Bor Phase I
Region
Japan

Condition
Condition Multiple myloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To Evaluate the safety of the combination of high dose melphalan with bortezomib as conditioning regimen for autologous stem cell transplant for multiple myeloma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety untill day 28 after SCT
Key secondary outcomes Overall response rate and Improvement rate of overall response at day 100 after SCT

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose of Bortezomib
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with multiple myeloma who receive first auto PBSCT at Keio university hospital
2) Patients who received PBSCC with high dose CY plus G-CSF
3) Patients who have not receive any chemotherapy without high dose CY whithin 30 days before SCT
4) Patients able to give written informed consent
Key exclusion criteria 1) Patients with abnormalities with liver function: AST >2.5X ULN, ALT >2.5X ULN, T-Bil >2X ULN(except for disease activity)
2) Patients with abnormalities with renal function: CRTNN >2.0 mg/dl
3)Patients with abnormalities in cardiac function or pulmonary function: EF <50%(assessed on cardiac ultrasonography)
, %VC <75%
4)Patients with organ dysfunction due to amyloidosis
5)Patients unable to differentiated from primary amyloidosis or POEMS syndrome
6)Patients with previous serious allergy to Bortezomib, Melphalan or dexamethasone
7)Patients with grade 2 or greater neuropathy due to Bortezomib
8)Patients with active infection
9) Patients with active viral hepatitis or HBs-Ag positive
10)Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease
11) Others: Inappropriate patients determined by a principal investigator or sub-investigators
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Okamoto
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email okamoto@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Kasahara
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email kasahara.hideno@gmail.com

Sponsor
Institute Division of Hematology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of Hematology, Keio University School of Medicine
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
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 08 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 12 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 08 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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