Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Conditions
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
Interventions
DRUGCarfilzomib
Intravenous carfilzomib, lenalidomide, dexamethasone
DRUGLenalidomide
Oral
DRUGDexamethasone
Oral or intravenous
Sponsors
Amgen
Dong-A University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 19 years 2. Relapsed and/or refractory multiple myeloma patients 3. Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.
Exclusion criteria
1. Patient who had not been treated with KRd combination therapy from the first cycle of treatment 2. Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactJi Hyun Lee, MD, Ph.D
Outcome results
None listed