UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043049 |
|---|---|
| Receipt number | R000049146 |
| Scientific Title | A multi-center retrospective observational study in patients with relapsed and refractory multiple myeloma receiving once-weekly carfilzomib dosing in combination with dexamethasone in a real-world setting in Japan (Weekly-CAR study) |
| Date of disclosure of the study information | 2021/01/19 |
| Last modified on | 2024/03/25 10:44:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multi-center retrospective observational study in patients with relapsed and refractory multiple myeloma receiving once-weekly carfilzomib dosing in combination with dexamethasone in a real-world setting in Japan (Weekly-CAR study)
Acronym
Weekly-CAR study
Scientific Title
A multi-center retrospective observational study in patients with relapsed and refractory multiple myeloma receiving once-weekly carfilzomib dosing in combination with dexamethasone in a real-world setting in Japan (Weekly-CAR study)
Scientific Title:Acronym
Weekly-CAR study
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy, safety, and treatment of wKd therapy in patients with relapsed or refractory (RR)MM in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate (ORR)
Key secondary outcomes
-Overall survival (OS)
-Progression-free survival at 12 months (PFS)
-Best overall response (BOR)
-Rate of CR or better (CRR)
-Clinical benefit rate (CBR)
-Disease Control Rate (DCR)
-Negativity rate of minimal residual disease (MRD)
-Duration of response (DOR)
-Duration of treatment (DOT)
-Time to response (TTR)
-Time to Best Response (TTBR)
-Continuation rate of carfilzomib at 12 months
-Safety
-Time to next treatment (TTNT)
-Relative dose intensity (RDI)
-Cumulative dose
-Number of Doses and Dose
-Efficacy and Safety by Patient Subgroup of Interest (Number of prior treatments, response to prior treatment, age, etc.)
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
-Male or female subjects <= 18 years of age at the time of registration.
-Subjects with RRMM
-Patients who newly started wKd therapy at the study center in approximately 1 year from November 2019 to December 2020
Key exclusion criteria
-Patients with hypersensitivity to ingredients of carfilzomib and dexamethasone
-Pregnant women
-Patients with initial doses of carfilzomib other than 20 mg/m2
-Patients with a history of recent administration of carfilzomib [Patients who have not been treated with carfilzomib for at least 6 months between the last dose of carfilzomib and the first dose of wKd therapy.]
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical, Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL
06-6263-2992
hi.matsumoto@ono.co.jp
Public contact
Name of contact person
| 1st name | Tsugio |
| Middle name | |
| Last name | Nakazato |
Organization
CIMIC HealthCare Institute Co., Ltd.
Division name
Quality Control Dept.
Zip code
105-0023
Address
1-1-1 Shibaura Minato-ku, Tokyo, Japan
TEL
03-6779-8160
Homepage URL
tsugio-nakazato.ha@cmicgroup.com
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-2992
n.nishiwaki@ono.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38420911/
Number of participants that the trial has enrolled
126
Results
We investigated data from the medical records of 126 Japanese patients with relapsed or refractory multiple myeloma. The overall response rate was 66.3%. The median progression-free survival was 9.5 months. The incidence of treatment-emergent adverse events of any grade and grade 3 or higher were 45.8 and 20.8%, respectively.
Results date posted
| 2024 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The Weekly-CAR study is a multicenter, observational study in patients with RRMM in a real-world setting in Japan. Data related to patients receiving wKd therapy were obtained from clinical records at 18 sites.
The inclusion criteria were as follows: age18 years or higher at the time of registration, patients with RRMM, wKd therapy started between November 2019 and December 2020. The exclusion criteria were as follows: hypersensitivity to carfilzomib or dexamethasone, pregnant patients, initial dose of carfilzomib other than 20 mg/m2, prior carfilzomib treatment within 6 months before starting wKd therapy.
Participant flow
Written informed consent to enroll in this study was obtained from patients. Opportunities for opt-out were provided for patients who had difficulty providing direct written consent, such as in instances of death or cessation of hospital visits.
Adverse events
The incidences of any grade, grade 3 or higher and SAEs were 48.3, 24.2 and 16.7%, respectively. The incidence of AEs leading to discontinuation was 21.7%. The incidences of any grade, grade 3 or higher and serious TEAEs were 45.8 and 20.8 and 14.2%, respectively
Outcome measures
The ORR was 66.3%. The proportion of patients with sCR and CR was 12.5 and 4.8%, respectively. The proportion of CR or higher and VGPR or higher was 17.3 and 33.7%, respectively. The disease control rate was 70.2%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | 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
This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049146
