UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025108 |
|---|---|
| Receipt number | R000028863 |
| Scientific Title | Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG) |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2025/11/04 17:04:08 |
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Basic information
Public title
Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)
Acronym
KOTOSG-CFZ observational study
Scientific Title
Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)
Scientific Title:Acronym
KOTOSG-CFZ observational study
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal the efficacy and the safety of Carfilzomib in the real-world practice in Japan by the Kyoto Clinical Hematology Study Group (KOTOSG) multi-instituitional observational analyses of patients' background, the content of Carfilzomib-included therapy, therapeutic outcome and efficacy, and safety including adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of Carfilzomib-containing therapy for multiple myeloma
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between 20 and 99 years old who received Carfilzomib-containing therapy
Key exclusion criteria
Patients who reject the enrollment in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hamatology and Oncology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5740
junkuro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hamatology and Oncology
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5740
Homepage URL
junkuro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Ethical Review Board form Medical research
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院、京都第一赤十字病院、京都第二赤十字病院、京都鞍馬口医療センター、愛生会山科病院、福知山市民病院(いずれも京都府)、松下記念病院（大阪府）、近江八幡総合医療センター、大津市民病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/cnr2.1476
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/cnr2.1476
Number of participants that the trial has enrolled
50
Results
We conducted a multicenter prospective study in 50 Asian RRMM patients treated with KRD (n=31) or KD (n=19) between 2017-2019. ORRs were 80.6% (KRD) and 73.7% (KD). Two-year PFS/OS were 58.5%/79.7% for KRD and 23.1%/52.6% for KD. BTZ and LEN resistance were independent adverse factors. Common AEs included hypertension, fever, fatigue, and infection; no severe heart failure occurred.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 05 | Day |
Baseline Characteristics
All patients were Asian. Thirty-one patients received KRD therapy and 19 received KD therapy. The median ages were 67 years (range, 41-81) in all 50 patients, 67 years in the KRD group, and 70 years in the KD group. Two patients were classified as ECOG-PS 3; 10 (20.0%) were frail based on the IMWG frailty score; and 17 (34.0%) were in ISS stage III. The median number of prior regimens was 2 (range, 1-7); the rates of prior exposure to BTZ and LEN were 90.0% (45/50) and 70.0% (35/50), respectively; and there were 21 (42.0%) and 19 (38.0%) BTZ- and LEN-refractory patients, respectively. The rates of histories of hypertension, diabetes mellitus and hyperlipidemia were 30.0%, 20.0%, and 18.8%, respectively. There was no significant difference in patient backgrounds between the KRD and KD groups.
Participant flow
Fifty patients with RRMM aged >20 years old who were scheduled to receive CFZ-based therapies (i.e., KRD or KD) at nine centers in the KOTOSG were registered in the study before initiation of treatment from June 2017 to August 2019. The sample size of this study was determined based on the rules of pilot test. The data cut-off date was March 31, 2021. No randomization was performed for selection of the treatment strategy for each patient, and the treatment modality was selected as KRD or KD at the discretion of a physician. KRD and KD were basically administered following the protocols established in pivotal trials, with dose modification due to AEs and/or a patient's condition permitted at the physician's discretion. Prophylaxis with acyclovir and sulfamethoxazole trimethoprim was recommended. The use of granulocyte-colony stimulating factor (G-CSF) for neutropenia was permitted.
Adverse events
No grade 5 AEs occurred in the study. Most AEs occurred within the first treatment course (hematological AEs: median 1 [range 1-14]; non-hematological AEs: median 1 [range 1-8]). Hematological AEs occurred in 43 patients (86.0%), including anemia (64.0%), lymphopenia (60.0%), thrombocytopenia (50.0%) and neutropenia (46.0%), and approximately half of hematologic AEs were grade 3 to 4. No febrile neutropenic episodes occurred in our cohort. CVAEs included hypertension in 21 patients (42.0%), arrhythmia in 7 (14.0%), dyspnea in 2 (4.0%), pulmonary edema in 1 (2.0%), and congestive heart failure in 1 (2.0%). Hypertension (HTN) was defined as event which manifested or deteriorated after CFZ-based treatment, and HTN, which required medical intervention, was defined as a grade 2 event. No ischemic heart disease or cardiomyopathy was detected. PN occurred in 3 patients (6.0%) who all had PN at baseline. There were significantly higher incidences of grade 3 to 4 HTN, all-grade nausea, and all-grade delirium in the KD group compared to the KRD group, but no difference in the frequency of other AEs between the two regimens.
Outcome measures
The primary endpoint was overall response rate (ORR). Treatment response was assessed using the IMWG criteria 23 and ORR was defined as the sum of rates of stringent complete response (sCR), CR, very good partial response (VGPR) and PR. The secondary endpoints were PFS, OS, and safety. PFS was defined as the time from the date of treatment initiation to progression or death, and OS as the time from the date of treatment initiation to death. PFS was censored at the end of CFZ-based treatment in patients who proceeded to a planned next treatment. AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0. Regarding hypertension, grade 2 or higher was defined as clinically significant.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 06 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 06 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 06 | Day |
Other
Other related information
Observation items in this study are listed as follows.
1 Bone marrow analysis
all nucleated cell count, myeloma cell ratio
2 Blood examination
complete blood cell count, LDH, AST, ALT, ALP, BUN, Cre, Na, K, Ca, IP, UA, CRP, beta-2-microglobulin, BNP(or NT-proBNP),immunoglobulin, serum free light chain, KL-6, PT, APTT, Fibrinogen, FDP, etc.
3 Urinary test
4 Radiologic examinations
Chest X-ray, Abdominal X-ray, CT, Cardiac ultrasonography, etc.
5 Physical examination
6 Adverse events evaluated by CTCAE v.4.0.
Management information
Registered date
| 2016 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028863
