UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027259 |
|---|---|
| Receipt number | R000031225 |
| Scientific Title | MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2023/05/11 14:22:14 |
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Basic information
Public title
MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry
Acronym
MRD assessment of MM patients who received carfilzomib by EuroFlow and a simple MFC
Scientific Title
MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry
Scientific Title:Acronym
MRD assessment of MM patients who received carfilzomib by EuroFlow and a simple MFC
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a simple multiparameter flow cytometry (MFC) method to assess minimal residual disease (MRD) in multiple myeloma (MM) patients.
Basic objectives2
Others
Basic objectives -Others
To compare MRD levels among EuroFlow, next-generation sequencing (NGS) and a simple MFC in Kameda medical center.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MRD correlation between a simple MFC (Kameda-Flow) and EuroFlow
Key secondary outcomes
(1) 1-year PFS and 3-year PFS post KRD treatment
(2) 1-year OS and 3-year OS post KRD treatment
(3) MRD negativity post KRD treatment
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
Active multiple myeloma patients who were diagnosed by IMWG criteria and relapse/refractory after the treatments of bortezomib/lenalidomide/thalidomide and have achieved complete response (CR) post carfilzomib+lenalidomide+dexamethasone (KRD) therapy.
Key exclusion criteria
Dementia patients who can not understand this clinical research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takamatsu |
Organization
Kanazawa University Hospital
Division name
Hematology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL
0762652276
takamaz@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki T |
| Middle name | |
| Last name | akamatsu |
Organization
Kanazawa University Hospital
Division name
Hematology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL
0762652276
Homepage URL
takamaz@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
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
Kanazawa University
Address
13-1 Takaramachi
Tel
076-265-2275
takamaz@staff.kanazawa-u.ac.jp
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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000027259
Publication of results
Published
Result
URL related to results and publications
https://ar.iiarjournals.org/content/43/1/157.long
Number of participants that the trial has enrolled
21
Results
As the best overall response post-KRD therapy, 52% (11/21) of patients achieved a MRD negative complete response, 71% (15/21) achieved stringent complete response/complete response, and 14% (3/21) achieved a very good partial response. MRD negativity was achieved in 12 of 16 (75%) and 14 of 21 (67%) patients during and after KRD treatment, respectively.
Results date posted
| 2022 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 01 | Day |
Baseline Characteristics
Patients whose age is more than 19 years old. Active myeloma patients according to IMWG criteria who received induction regimen including bortezomib or lenalidomide or thalidomide and were diagnosed with relapse/refractory multiple myeloma (RRMM). RRMM was treated with carfilzomib + lenalidomide + dexamethasone (KRD) and ahieved CR or sCR. There are no restriction about the cycles and dose of KRD.
Participant flow
Patients participated after the informed consent was obtained.
Adverse events
Fifteen (71%) patients reported grade 3/4 AEs. Grade 3/4 non-hematologic AEs included hypertension (14%), elevated liver function test results (14%), heart failure (5%), pneumonia (5%), sepsis (5%), fatigue (5%), and peripheral neuropathy (5%). Hematological grade 3/4 toxicities included thrombocytopenia (29%), lymphopenia (14%), and neutropenia (14%). No grade 5 AEs or treatment-related deaths were reported throughout the treatment duration.
Outcome measures
MRD correlation between a simple MFC (Kameda-Flow) and EuroFlow
(1) 1-year PFS and 3-year PFS post KRD treatment
(2) 1-year OS and 3-year OS post KRD treatment
(3) MRD negativity post KRD treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bone marrow (BM) of 6mL is aspirated and anaylzed as follows: MRD in BM of 2mL by EuroFlow; MRD in BM of 2mL by MFC in Kameda Medical Center: 2mL by NGS.
Management information
Registered date
| 2017 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031225
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/05/07 | KRD_EuroFlow_ホームページ掲載文書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
