Long-term KRd in Relapsed and/or Refractory Multiple Myeloma
Study Details
Study Description
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
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PFS difference according to the high-risk disease subgroups and previous treatment
-
OS
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Overall response rate and clinical benefit rate
-
Duration of response To evaluate the safety and tolerability of KRd in RRMM patients
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Relapsed and/or refractory multiple myeloma Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status |
Drug: Carfilzomib
Intravenous
carfilzomib, lenalidomide, dexamethasone
Other Names:
Drug: Lenalidomide
Oral
Other Names:
Drug: Dexamethasone
Oral or intravenous
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion criteria
-
Patients ≥ 19 years
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Relapsed and/or refractory multiple myeloma patients
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Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.
Exclusion criteria
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Patient who had not been treated with KRd combination therapy from the first cycle of treatment
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Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dong-A University Hospital
- Amgen
Investigators
- Principal Investigator: Sung-Hyun Kim, MD, Ph.D, Dong-A University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- DAUHIRB-22-081