UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048285 |
|---|---|
| Receipt number | R000054885 |
| Scientific Title | Elucidation of DNA mutation dynamics and identification of the immunologic factors affecting the efficiency in ixazomib maintenance therapy for multiple myeloma patients intolerant to lenalidomide maintenance therapy due to frailty or adverse events |
| Date of disclosure of the study information | 2022/07/14 |
| Last modified on | 2025/01/05 09:44:41 |
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Basic information
Public title
Elucidation of efficacy, safety, mutations, and immunologic factors in ixazomib maintenance therapy for transplant-ineligible patients with multiple myeloma intolerant to lenalidomide therapy due to frailty or adverse events
Acronym
Ixazomib-maintenance therapy for transplant-ineligible patients intolerant to lenalidomide
Scientific Title
Elucidation of DNA mutation dynamics and identification of the immunologic factors affecting the efficiency in ixazomib maintenance therapy for multiple myeloma patients intolerant to lenalidomide maintenance therapy due to frailty or adverse events
Scientific Title:Acronym
Ixazomib-maintenance therapy for transplant-ineligible patients intolerant to lenalidomide: IMTIL
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the efficacy and safety of ixazomib maintenance in transplant-ineligible patients who cannot receive standard dose of lenalidomide in induction therapy or continuous therapy due to adverse events or frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
(1)Identification of driver mutations using whole-genome sequencing (WGS) and quantification of the size of clones with driver mutations in BM using digital droplet polymerase chain reaction (PCR).
(2)Examination of the dynamics of IgG, IgA, IgM as well as flow cytometric analysis of immune related genes in myeloma and effector cells.
(3)Time to Next Treatment (TTNT).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary entry
1)Transplant-ineligible multiple myeloma patients.
2)Intolerant to 25mg dose of lenalidomide.
3)Those plan to start maintenance therapy with ixazomib.
4)Those can give a written consent to participate in this research.
Secondary entry
1)Those completed primary entry and gained effectiveness such as PR and better after induction therapy.
2)Lenalidomide-intolerant patients who gained effectiveness such as PR and better after induction therapy.
3)Those plan to start maintenance therapy with ixazomib for two years.
Key exclusion criteria
Primary entry
1)Those have a past history of allergy to ixazomib
2)Pregnant woman or possible pregnant woman
Secondary entry
1)Those were treated by 25mg dose of lenalidomide as an induction therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Imai |
Organization
Dokkyo Medical University
Division name
Department of Hematology and Oncology
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
imaiyo-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Imai |
Organization
Dokkyo Medical University
Division name
Department of Hematology and Oncology
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Homepage URL
https://dept.dokkyomed.ac.jp/dep-m/hematol/index.html
imaiyo-tky@umin.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Institute of Medical Science, University of Tokyo
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo
Tel
03-6409-2035
ken-jo@ims.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
IISR-2021-200090
Org. issuing International ID_1
Takeda Pharmaceutical Company Limited
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
Study Aim
Evaluate the efficacy and safety of ixazomib maintenance in transplant-ineligible patients who cannot receive standard dose of lenalidomide in induction therapy or continuous therapy due to adverse events or frailty.
Exploratory Aim
Establish a new therapeutic effect assessment method by capturing the DNA mutation dynamics
Explore the immunologic factors affecting the efficiency by Progression Free Survival (PFS) or Over all Response Rate (ORR)
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054885
