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)
Not Applicable
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000043049
- Lead Sponsor
- Ono Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
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.]
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method -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.)