UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040635 |
|---|---|
| Receipt number | R000046376 |
| Scientific Title | Safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after a first high dose therapy |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2021/07/09 19:51:26 |
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Basic information
Public title
Safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after a first high dose therapy
Acronym
Allo-PBSCT for relapsed multiple myeloma patients
Scientific Title
Safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after a first high dose therapy
Scientific Title:Acronym
Allo-PBSCT for relapsed multiple myeloma patients
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 the safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after first high dose therapy following by autologous stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Non-relapse mortality(NRM) at 100 days after allogeneic peripheral blood stem cell transplantation
Key secondary outcomes
Adverse event
Engraftment
Response rate
NRM at 1-,2-,and 3-years
Acute and chronic GVHD
Relapse rate
Progression free survival
Overall survival
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
1.re-auto PBSCT phase
High-dose melphalan and bortezomib followed by auto-PBSCT
Between 40-120 days after auto-PBSCT,patients proceeded to RIC allo-PBSCT
2.Allogeneic PBSCT phase
fludarabine 30mg/m2 i.v. on days -4 to -2 and 2Gy TBI on day -1 followed by allo-PBSCT
*GVHD prophylaxis(CyA and sMTX on days 1,3,6 and bortezomib on days 1,4,7)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patient who relapse <18 months after first or tandem auto-PBSCT.
2.>=PR after salvage treatment.
3.ECOG PS is 0-2.
4.Patient for whom a HLA-matched sibling donor was identified.
5.Liver function:serum T-Bil <= 2 times the upper limit of normal.
6.Renal function:Ccr >= 40ml/min.
7.Heart function:EF >= 40%
8.The other major organ functions are normal.
9.Patient who provided written consents for this study.
Key exclusion criteria
1.Uncontrolled active infection.
2.Cardiac amyloidosis.
3.Patient who is judged to be medically unfit by his/her physician.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Miwa |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56, Akabanedai, Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
miwaamoromniavincit@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56, Akabanedai, Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
Homepage URL
daisukekud@jadecom.jp
Sponsor or person
Institute
Department of hematology, Tokyo-kita Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo-kita Medical Center
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
Tel
03-5963-3311
tk-umin@tokyokita-jadecom.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
東京北医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046376
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
