UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059843 |
|---|---|
| Receipt number | R000068416 |
| Scientific Title | DaraPIONEER (Japan): Panel Interview of ONcology practices with Emergent Experience of Daratumumab in the Real World (Japan) |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/20 18:41:45 |
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Basic information
Public title
DaraPIONEER (Japan): Panel Interview of ONcology practices with Emergent Experience of Daratumumab in the Real World (Japan)
Acronym
DaraPioneer - Japan
Scientific Title
DaraPIONEER (Japan): Panel Interview of ONcology practices with Emergent Experience of Daratumumab in the Real World (Japan)
Scientific Title:Acronym
DaraPioneer - Japan
Region
| Japan |
Condition
Condition
Newly Diagnosed Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
A prospective, qualitative research study designed to understand the multifaceted convenience and real-world value (e.g., time and motion, staff burden, patient experience) and perspectives regarding future use among Japanese hematologists with experience treating patients with TIE NDMM with Daratumumab SC-based regimens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
As this study is qualitative in nature, typical outcome measures will not be collected for quantitative analysis.
Key themes will include:
1) Impact on clinic Time and Motion of Daratumumab SC-based regimens (including comparison to other IV regimens)
2) Perceived Staff Burden and Preference related to Daratumumab SC-based regimens
3) HCPs' perspective on Patient Experience and Preference, focusing on aspects that reduce treatment burden
4) Physicians' perspectives on the future therapeutic landscape and positioning of Daratumumab SC-based regimens
Key secondary outcomes
Not applicable
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
| 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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Ishizawa |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Div.
Zip code
101-0065
Address
3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065
TEL
03-4411-7700
rishizaw@its.jnj.com
Public contact
Name of contact person
| 1st name | Tetsuri |
| Middle name | |
| Last name | Suzuki |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai Chiyoda-ku, Tokyo 101-0062
TEL
03-5294-8393
Homepage URL
suzuki.49352@intage.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
Japan
Other related organizations
Co-sponsor
INTAGE Healthcare Inc., Plamed Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068416
