Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059842) titled 'TalPioneer - Japan: Panel Interview of ONcology practices with Emergent Experience of Talquetamab in the Real World (Japan)' 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 - 1.To characterize current talquetamab treatment strategies and administration practices, including patient profiles and treatment sequencing, as well as dosing schedules and dose modifications during the initial step-up phase and ongoing treatment among Japanese healthcare providers for their patients with RRMM.
2.To characterize how Japanese healthcare providers mitigate, monitor, and manage treatment-related AEs including CRS, neurotoxicity, and particularly GPRC5D-related AEs such as oral, skin and nail disorders.
3.Investigate how providers evaluate their current and idealized administration models, including perceived barriers and facilitators to attainment of these models in clinical practice, as well as how they envision future best practices for talquetamab, including its place in the RRMM treatment armamentarium (e.g., combination therapies, mono use in earlier lines of therapy, retreatment/reinitiation after CAR-T therapy).
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.18+ years of age at the time of the study participation.
2.Board certified in oncology or hematology and currently practicing medicine in Japan.
3.Japanese-language proficient.
4.Provides verbal consent to all terms of research participation.
5.Willing and able to participate in a recorded web-based video conferencing interview.
6.Cohort A (In Depth Interview): Has prescribed and treated at least two (2) patients with RRMM with talquetamab in a real-world setting.
7.Cohort B (Roundtable Discussion): Participated in talquetamab mono-therapy clinical trials (NCT04634552 and/or JRCT2061210001) and has treated at least two (2) patients with RRMM with talquetamab.
Key exclusion criteria - Any individual who does not meet all inclusion criteria.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 04 Day
Date of IRB - 2025 Year 11 Month 13 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068414
Disclaimer: Curated by HT Syndication.
