Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059272) titled 'Specified drug use-results survey of TALVEY Subcutaneous Injection in patients with relapsed or refractory multiple myeloma' on Dec. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Janssen Pharmaceutical K.K.
Condition:
Condition - relapsed or refractory multiple myeloma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
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 Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 10 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2032 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067796
Disclaimer: Curated by HT Syndication.
