UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059272 |
|---|---|
| Receipt number | R000067796 |
| Scientific Title | Specified drug use-results survey of TALVEY Subcutaneous Injection in patients with relapsed or refractory multiple myeloma |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/02 19:30:36 |
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Basic information
Public title
Specified drug use-results survey of TALVEY Subcutaneous Injection in patients with relapsed or refractory multiple myeloma
Acronym
TAL1L
Scientific Title
Specified drug use-results survey of TALVEY Subcutaneous Injection in patients with relapsed or refractory multiple myeloma
Scientific Title:Acronym
TAL1L
Region
| Japan |
Condition
Condition
relapsed or refractory multiple myeloma
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of subcutaneous injection of TALVEY in patients with relapsed or refractory multiple myeloma (only when standard treatment is difficult) who receive this drug for the first time under routine clinical practice.
In this survey, the following items will be set as safety specifications, and the occurrence status will be monitored.
Safety specification: Cerebellar disorder such as ataxia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To collect adverse event information and evaluate the safety in patients who receive this drug for the first time.
Observation period: 12 months from the date of treatment commencement (52 weeks) (allowance: 14 days)
*However, if observation becomes impossible by the end of the observation period due to transfer of a registered patient, death, etc., the observation period will end at the time point when observation becomes impossible.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received subcutaneous injection of TELVY for the first time in patients with relapsed or refractory multiple myeloma (only when standard treatments are difficult).
Key exclusion criteria
OFF LABEL USE
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | koyama |
Organization
R & D
Division name
Medical affairs Delivery unit
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo
TEL
03-4411-5136
Tkoyama4@its.jnj.com
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Nomura |
Organization
R & D
Division name
Medical affairs Delivery unit
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo
TEL
03-4411-5136
Homepage URL
fnomura@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
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
NA
Address
NA
Tel
NA
NA
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
| 2025 | Year | 12 | 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
| 2025 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational survey under clinical use
Management information
Registered date
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067796
