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

• Conditions: Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
• Interventions: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

• Registration Number: NCT05495620
• Lead Sponsor: Dong-A University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2022-07-05
• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-01-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed and/or refractory multiple myeloma	Carfilzomib	Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
Relapsed and/or refractory multiple myeloma	Lenalidomide	Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status
Relapsed and/or refractory multiple myeloma	Dexamethasone	Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status

Primary Outcome Measures

Name	Time	Method
Progression-free survival	up to 54 months	the time from the first date of KRd to the date of disease progression or death or censored date

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 54 months	the time from the first date of KRd treatment to the time of death or censored date
Overall response rate, clinical benefit rate	up to 54 months	the proportion of patients who achieved a PR or better, which response is defined by the IMWG criteria, the proportion of patients who achieved a MR or better
Duration of response	up to 54 months	the time from the first date of response to the time of disease progression or death or censored date
Toxicity profile	up to 2 years	toxicities as determined by the incidence of clinical and laboratory findings occurred from the time of the first date of KRd treatment to the date of disease progression or death or censored date