UMIN-CTR Clinical Trial

Basic information
Public title	Quantification of soluble-form signaling lymphocytic activation molecule family 7 (SLAMF7) and comprehensive gene expression analysis in serum samples among patients with relapsed/refractory multiple myeloma (RRMM): A multicenter prospective observational study (FBMTG RRMM18).
Acronym	Quantification of SLAMF7 and comprehensive gene expression analysis in serum samples among patients with RRMM:(FBMTG RRMM18).
Scientific Title	Quantification of soluble-form signaling lymphocytic activation molecule family 7 (SLAMF7) and comprehensive gene expression analysis in serum samples among patients with relapsed/refractory multiple myeloma (RRMM): A multicenter prospective observational study (FBMTG RRMM18).
Scientific Title:Acronym	Quantification of SLAMF7 and comprehensive gene expression analysis in serum samples among patients with RRMM:(FBMTG RRMM18).
Region	Japan

Condition
Condition	multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate whether serum soluble SLAMF7 (sSLAMF7) could be a biomarker predicting tumor burden, treatment response, or outcome of RRMM patients. To evaluate the correlation between serum sSLAMF7 value and bone marrow (BM) sSLAMF7 value or surface SLAMF7 expression level of BM MM cells. To perform comprehensive mutation analysis in MM-related genes by using BM samples and evaluate an association between particular mutations and drug resistance or outcome.
Basic objectives2	Others
Basic objectives -Others	Serum sSLAMF7 level and its indicative value for treatment response or prognosis among RRMM patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum sSLAMF7 level and its indicative value for treatment response or prognosis among RRMM patients.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
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Blinding
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. RRMM patients based on IMW definition. 2. Age of 20 to 85 years. 3. Treated with 1-3 lines of prior chemo-radiotherapy (and remained effective salvage treatment). 4. Signed consent form to participate in this study.
Key exclusion criteria	1. Treated with >=4 lines of prior chemo-radiotherapy. 2. Diagnosed as solitary plasmacytoma, plasma cell leukemia, or POEMS syndrome. 3. Positive results of either HIV-antibody, HBs-antigen, or HCV-antibody(except for HCV-PCR negativity). 4. Uncontrolled following diseases:liver dysfunction, renal dysfunction, cardiac dysfunction, respiratory dysfunction, diabetes, hypertension, infection. 5. Active advanced double-cancer (concurrently existed or <=5 years of disease free period, excluding Carcinoma in situ at uterine cervix, stomach, or colon). 6. Severe mental disorders such as schizophremia. 7. Pregnant women, possible of pregnancy, or during lactation. 8. Judged as inappropriate to participate in this study by doctor.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Miyamoto
Organization	Kyushu University Hospital
Division name	Hematology and Oncology
Zip code	812-9582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Study Office Middle name Last name FBMTG
Organization	Fukuoka Blood and Marrow Transplant Group
Division name	FBMTG Study Office
Zip code	812-9582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Homepage URL
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Fukuoka Blood and Marrow Transplant Group
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb Company
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	Kyushu University Hospital
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-u.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 01 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 03 Month 18 Day
Date of IRB	2019 Year 03 Month 29 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

To evaluate whether serum soluble SLAMF7 (sSLAMF7) could be a biomarker predicting tumor burden, treatment response, or outcome of RRMM patients. To evaluate the correlation between serum sSLAMF7 value and bone marrow (BM) sSLAMF7 value or surface SLAMF7 expression level of BM MM cells. To perform comprehensive mutation analysis in MM-related genes by using BM samples and evaluate an association between particular mutations and drug resistance or outcome.

Management information
Registered date	2019 Year 06 Month 26 Day
Last modified on	2019 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042364