UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058084 |
|---|---|
| Receipt number | R000066384 |
| Scientific Title | Drug use-results survey of TECVAYLI Subcutaneous Injection (relapsed or refractory multiple myeloma) |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/05 00:21:41 |
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Basic information
Public title
Drug use-results survey of TECVAYLI Subcutaneous Injection in patients with relapsed or refractory multiple myeloma (limited to patients who are refractory to standard treatments)
Acronym
TEC1U
Scientific Title
Drug use-results survey of TECVAYLI Subcutaneous Injection (relapsed or refractory multiple myeloma)
Scientific Title:Acronym
TEC1U
Region
| Japan |
Condition
Condition
relapsed or refractory multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This survey aims to investigate the risk factors of immune effector cell-associated neurotoxicity syndrome (Hereinafter referred to as ICANS) and to investigate the safety of Tecbeilii Subcutaneous Injection 30 mg and 153 mg(Hereinafter referred to as this drug) under actual use conditions in patients with relapsed or refractory multiple myeloma who are treated for the first time (only if standard treatments are difficult).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety(Adverse Events,Adverse reactions)
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 with relapsed or refractory multiple myeloma (limit the use to patients who are refractory or intolerant to standard treatments) who have received this drug in accordance with the approved indication and dosage and administration for the first time.
Key exclusion criteria
After conclusion of the contract, the investigator will enter patient information through the "Patient Registration Screen" in the EDC system within 30 days after the start date of treatment with this drug (the start date of treatment with this drug is regarded as Day 1).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Koyama |
Organization
Janssen Pharmaceuticals K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-Kanda3-chome, Chiyoda-ku, Tokyo
TEL
090-20379359
tkoyama4@its.jnj.com
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shirai |
Organization
Janssen Pharmaceuticals K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-Kanda3-chome, Chiyoda-ku, Tokyo
TEL
070-4179-4492
Homepage URL
hshirai3@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceuticals K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceuticals K.K.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Janssen Pharmaceuticals K.K.
Address
5-2, Nishi-Kanda3-chome, Chiyoda-ku, Tokyo
Tel
070-4179-4492
hshirai3@its.jnj.com
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 | 06 | Month | 16 | 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 | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Survey period:
Registration period: June 16, 2025 to June 30, 2032 (7 years)
Survey period: June 16, 2025 to December 31, 2033 (8.5 years)
Observation period:
The observation period will be 24 weeks from the start date of administration of this drug.
If the treatment is discontinued by the end of the observation period, the observation period will be up to the date of the last dose +14 days. If the observation becomes impossible due to transfer to another hospital, death, etc., the observation period will be up to the time point at which the observation becomes impossible.
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066384
