UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058306 |
|---|---|
| Receipt number | R000065843 |
| Scientific Title | Treatment Workflow Study Comparing Intravenous and Subcutaneous Administration of Isatuximab for Multiple Myeloma Treatment: Understanding Impact on Healthcare Resource Utilization from HCPs' Perspective |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 20:11:01 |
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Basic information
Public title
Treatment Workflow Study Comparing Intravenous and Subcutaneous Administration of Isatuximab for Multiple Myeloma Treatment: Understanding Impact on Healthcare Resource Utilization from HCPs' Perspective
Acronym
Treatment Workflow Study Comparing Intravenous and Subcutaneous Administration of Isatuximab for Multiple Myeloma Treatment: Understanding Impact on Healthcare Resource Utilization from HCPs' Perspective
Scientific Title
Treatment Workflow Study Comparing Intravenous and Subcutaneous Administration of Isatuximab for Multiple Myeloma Treatment: Understanding Impact on Healthcare Resource Utilization from HCPs' Perspective
Scientific Title:Acronym
Treatment Workflow Study Comparing Intravenous and Subcutaneous Administration of Isatuximab for Multiple Myeloma Treatment: Understanding Impact on Healthcare Resource Utilization from HCPs' Perspective
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the workflow associated with intravenous administration of Isatuximab versus subcutaneous administration of Isatuximab for the treatment of multiple myeloma from a healthcare system perspective.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the burden of physicians, nurses, pharmacists regarding subcutaneous (SC)/intravenous (IV) injectables for multiple myeloma treatment, specifically focusing on "administration of SC (OBI)/SC (manual) /IV injectable" and "post-treatment drug administration and monitoring" from their perspectives.
_Burden of SC (OBI)/SC (manual)/IV administration
*HCP's (physicians, nurses, pharmacists) capability of doing any other tasks and the burden on a patient during the process of the administrations of SC (OBI)/SC (manual) /IV injections for the treatment of multiple myeloma. The evaluation questioner consists of "administration of SC (OBI)/SC (manual) /IV injectable" and "post-treatment drug administration and monitoring".
OBI: on-body injector
Key secondary outcomes
To evaluate the time required by physicians, nurses, and pharmacists regarding subcutaneous (SC)/intravenous (IV) injectables for multiple myeloma treatment, specifically focusing on "administration of SC (OBI)/SC (manual) /IV injectable" and "post-treatment drug administration and monitoring" from their perspectives.
_Time required for SC (OBI)/SC (manual) /IV administration among physicians, nurses, and pharmacists
*The average time required for the steps include "administration of SC (OBI)/SC (manual) /IV injectable" and "post-treatment drug administration and monitoring".
To evaluate the current awareness in HCPs (physicians, nurses, pharmacists) from their perspectives regarding the use of SC/IV injectables in multiple myeloma treatment.
_Benefits of and issues with SC/IV administration perceived by physicians, nurses, and pharmacists
*Evaluate the questions regarding the administrations of SC/IV injections in the treatment of multiple myeloma on a five-point scale of agreement or disagreement
OBI: on-body injector
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
[Physicians]
Physicians who meet all of the following inclusion criteria will be included:
1_Belongs to the department of hematology
2_Decides treatment for multiple myeloma on their own
3_Has been involved in the treatment (such as prescription) with intravenous (IV) injectables for multiple myeloma patients
4_Has been involved in the treatment (such as prescription) with subcutaneous (SC) injectables (isatuximab) for multiple myeloma patients
5_Agreed to participate in this survey
[Nurses]
Nurses who meet all of the following inclusion criteria will be included:
1_Has been involved in multiple myeloma treatment
2_Has been involved in the treatment (such as administration) with IV injectables for multiple myeloma patients (not limited to clinical trials)
3_Has been involved in the treatment (such as administration) with SC injectables (isatuximab) for multiple myeloma patients
4_Agreed to participate in the survey
[Pharmacists]
Pharmacists who meet all of the following inclusion criteria will be included:
1_Has dispensed IV injections for the treatment of multiple myeloma at least once (not limited to clinical trials)
2_Has been involved in multiple myeloma treatment (such as dispensation of the drug and medical supplies) with SC injectables (isatuximab)
3_Agreed to participate in this survey
Key exclusion criteria
Not applicable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nami |
| Middle name | |
| Last name | Tagami |
Organization
Sanofi K.K.
Division name
Oncology Medical in Specialty Care
Zip code
160-0023
Address
Tokyo Opera City Tower, 3-20- 2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-3000
Nami.Tagami@sanofi.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kusaka |
Organization
Social Survey Research Information Co., Ltd.
Division name
Healthcare Business Intelligence
Zip code
162-0067
Address
NMF Shinjuku EAST Bldg., 10-5 Tomihisacho, Shinjuku-ku, Tokyo, Japan
TEL
03-6709-9710
Homepage URL
HOR@ssri.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation
Address
1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.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 | 27 | 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 | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory objectives
To evaluate the burden and time required of physicians, nurses, and pharmacists regarding subcutaneous (SC)/intravenous (IV) injectables for multiple myeloma treatment, specifically focusing on "preparation before administration" and "management of treatment-related systemic reactions" from their perspectives.
_Burden of SC (OBI)/SC (manual) /IV administration
*HCP's (physicians, nurses, and pharmacists) capability of doing any other tasks and the burden on a patient during the process of the administrations of SC (OBI)/SC (manual) /IV injections for the treatment of multiple myeloma. The evaluation questioner consists of "preparation before administration" and "management of treatment-related systemic reactions".
_Time required for SC (OBI)/SC (manual) /IV administration among physicians, nurses, and pharmacists.
*The average time required for the steps include "preparation before administration" and "management of treatment-related systemic reactions".
To evaluate the time required and the burden that is placed on as well as awareness in physicians, nurses, and pharmacists from their perspectives regarding the use of SC/IV injectables for the multiple myeloma treatment by subgroup.
_The primary and secondary endpoints in the subgroups
*The key subgroups are assumed to be as follows:
1_Types of HCPs
2_Type of facility
OBI: on-body injector
Management information
Registered date
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065843
