UMIN-CTR Clinical Trial

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
Email	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
Email	daisukekud@jadecom.jp

Sponsor
Institute	Department of hematology, Tokyo-kita Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046376