NCT05495620

Long-term KRd in Relapsed and/or Refractory Multiple Myeloma

Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Dong-A University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Research question: Is KRd therapy effective and safe in the real-world Asian patients? Primay objective: To evaluate the effectiveness of KRd in RRMM patients Secondary objectives: To evaluate the effectiveness of investigational treatment strategy by * PFS difference according to the high-risk disease subgroups and previous treatment * OS * Overall response rate and clinical benefit rate * Duration of response To evaluate the safety and tolerability of KRd in RRMM patients

Detailed description

Key study variables: Demographic data, ISS, R-ISS, cytogenetic abnormalities on FISH and G-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, MM-related symptoms, whether or not M protein has increased twice or more in 2-3 months at the time of KRd commencement, response to KRd therapy, duration of KRd treatment, adverse events during KRd therapy, disease progression and progression date, survival, and censored date or day of death

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	Carfilzomib	Intravenous carfilzomib, lenalidomide, dexamethasone
DRUG	Lenalidomide	Oral
DRUG	Dexamethasone	Oral or intravenous

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-31
• Completion: 2023-09-30
• First posted: 2022-08-10
• Last updated: 2022-08-10