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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name