UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037176 |
|---|---|
| Receipt number | R000042364 |
| 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). |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/26 09:28:54 |
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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
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 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
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
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood and Marrow Transplant Group
Institute
Department
Personal name
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042364
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