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

Dong-A University Hospital300 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Multiple Myeloma in Relapse Multiple Myeloma, Refractory

Interventions

CarfilzomibDRUG

Intravenous carfilzomib, lenalidomide, dexamethasone

LenalidomideDRUG

Oral

DexamethasoneDRUG

Oral or intravenous

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression-free survival

the time from the first date of KRd to the date of disease progression or death or censored date

Time frame: up to 54 months

Secondary Outcomes

Overall survival

the time from the first date of KRd treatment to the time of death or censored date

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: up to 2 years

Central Contacts

Ji Hyun Lee, MD, Ph.D

CONTACT

82-51-240-2915 hidrleejh@dau.ac.kr

Data from ClinicalTrials.gov

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