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)

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) - Weekly-CAR study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043049

Enrollment

150

Registered

2021-01-19

Start date

2021-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.]

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR)	—

Secondary

Measure	Time frame
-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.)	—

Measure

Time frame

-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.)

—

Countries

Japan

Contacts

Public ContactTsugio Nakazato

CIMIC HealthCare Institute Co., Ltd. Quality Control Dept.

tsugio-nakazato.ha@cmicgroup.com03-6779-8160

Outcome results