UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012789 |
|---|---|
| Receipt number | 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 10:31:59 |
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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
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
kasahara.hideno@gmail.com
Sponsor or person
Institute
Division of Hematology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014940
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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