UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046988 |
|---|---|
| Receipt number | R000053611 |
| Scientific Title | Prospective observational study II to assess the prognosis of patients with plasma cell neoplasms in Japan |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2022/06/07 13:44:00 |
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Basic information
Public title
Prospective observational study for multiple myeloma (MM) in Japan
Acronym
JSH-MM-20
Scientific Title
Prospective observational study II
to assess the prognosis of patients with plasma cell neoplasms in Japan
Scientific Title:Acronym
JSH-MM-20
Region
| Japan |
Condition
Condition
Newly diagnosed plasma cell neoplasms
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To figure out the prognosis and the prognostic factor in patients with plasma cell neoplasms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year survival rate of MM patients including non-secretory myeloma patients who received drug therapy in the new drug era
Key secondary outcomes
To clarify the following in patients with MM who received drug therapy:
overall response rate (ORR);
progression-free survival (PFS);
time to next treatment (TNT);
treatment-free interval (TFI);
overall survival (OS);
presence or absence of differences in efficacy endpoints by stage, according to differences in initial induction therapy and;
presence or absence of differences in these efficacy endpoints by chromosomal risk category;
understanding of the actual condition of secondary cancer development after the start of initial treatment; and
understanding of the actual condition of arteriovenous thrombosis (including pulmonary embolism) after diagnosis.
To clarify the following in plasma cell neoplasms other than MM, systemic AL amyloidosis and POEMS syndrome, which include MGUS, smoldering myeloma, solitary plasmacytoma, plasma cell leukemia:
Overall survival;
understanding of the actual situation including disease type transition.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with MGUS, smoldering myeloma, MM, non-secretory myeloma, solitary plasmacytoma of bone/soft tissue, or plasma cell leukemia according to IMWG classification.
(2) To use the IMWG Diagnostic Criteria 2014 edition as diagnostic criteria [6].
(3) Newly diagnosed after January 1, 2022.
(4) Patients registered in the epidemiological survey of the Japanese Society of Hematology "Blood Disease Registration" or the National Hospital Organization Network Joint Research "Disease Registration in Blood and Hematopoietic Diseases".
Key exclusion criteria
None
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Iida |
Organization
Nagoya City University Institute of Medical and Pharmaceutical Sciences
Division name
Hematology and Oncology
Zip code
467-8601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku, Nagoya City,Aichi 467-8601,Japan
TEL
052-853-8738
iida@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Narita |
Organization
Nagoya City University Institute of Medical and Pharmaceutical Sciences
Division name
Hematology and Oncology
Zip code
467-8601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku, Nagoya City,Aichi 467-8601,Japan
TEL
052-853-8738
Homepage URL
jsh-mm-20@hci-bc.com
Sponsor or person
Institute
THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka Ethics Committee
Address
812-0054,3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel
092-643-7171
mail@crnfukuoka.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
| 2022 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
http://www.jshem.or.jp/modules/research/index.php?content_id=17
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
| 2021 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In prospective observational study in patients with multiple myeloma, several factors such as age, clinical stage, cytogenetic risk group and difference of initial therapies are considered to influence on the efficacy endpoints such as overall survival and progression-free survival.
In patients with MGUS and smouldering myeloma, several factors such as paraprotein level, marrow plasma cell percentage, serum free light chain ratio are considered to influence on the disease progression.
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053611
