Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059843) titled 'DaraPIONEER (Japan): Panel Interview of ONcology practices with Emergent Experience of Daratumumab in the Real World (Japan)' on Dec. 1.

Study Type: Observational

Primary Sponsor: Institute - Janssen Pharmaceutical K.K.

Condition: Condition - Newly Diagnosed Multiple Myeloma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To characterize the multifaceted convenience and real-world value proposition of Daratumumab subcutaneous (SC)-based regimens for the treatment of transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM) from the perspective of Japanese hematologists.

Specific objectives are: 1.To characterize the impact on clinic Time and Motion (e.g., treatment schedule, preparation time, injection time) elucidating perceived efficiencies compared to other IV-based standard-of-care (SoC) regimens (e.g., IsaVRd). 2.To explore the perceived Staff Burden and Preference, investigating the underlying reasons for clinical preference for Daratumumab SC-based regimens. 3.To understand the HCPs' perspective on the Patient Experience and Preference, focusing on aspects that reduce treatment burden and contribute to patient preference. 4.To explore physicians' perspectives on the future therapeutic landscape and the positioning of Daratumumab SC-based regimens. 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.Has prescribed and managed at least one TIE NDMM patient in a real-world setting, with clinical experience of either: a) A Daratumumab SC-based regimen (e.g., DRd, DVRd), OR b) An intravenous (IV) anti-CD38 antibody-based regimen (e.g., IsaVRd) (Note: Recruitment will prioritize respondents with experience in both regimen types.) 4.Japanese-language proficient. 5.Provides verbal consent to all terms of research participation. 6.Willing and able to participate in a recorded web-based video conferencing interview. Key exclusion criteria - Any individual who does not meet all inclusion criteria. Target Size - 10

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 01 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068416

Disclaimer: Curated by HT Syndication.