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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Multiple Myeloma in Relapse, Multiple Myeloma, Refractory

Intervention / Treatment
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* Drug: Carfilzomib
* Drug: Lenalidomide
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients ≥ 19 years Relapsed and/or refractory multiple myeloma patients Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020. Exclusion criteria Patient who had not been treated with KRd combination therapy from the first cycle of treatment Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsed and/or refractory multiple myeloma<br>Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status | Drug: Carfilzomib<br>* Intravenous carfilzomib, lenalidomide, dexamethasone<br>* Other names: Kyprolis;Drug: Lenalidomide<br>* Oral<br>* Other names: Revlimid;Drug: Dexamethasone<br>* Oral or intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the time from the first date of KRd to the date of disease progression or death or censored date | up to 54 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time from the first date of KRd treatment to the time of death or censored date | up to 54 months | 
| Overall response rate, clinical benefit rate | 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 | up to 54 months | 
| Duration of response | the time from the first date of response to the time of disease progression or death or censored date | up to 54 months | 
| Toxicity profile | 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 | up to 2 years |