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Trial Title:
Long-term KRd in Relapsed and/or Refractory Multiple Myeloma
NCT ID:
NCT05495620
Condition:
Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Intravenous
carfilzomib, lenalidomide, dexamethasone
Arm group label:
Relapsed and/or refractory multiple myeloma
Other name:
Kyprolis
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Oral
Arm group label:
Relapsed and/or refractory multiple myeloma
Other name:
Revlimid
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Oral or intravenous
Arm group label:
Relapsed and/or refractory multiple myeloma
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
Criteria for eligibility:
Study pop:
Relapsed and/or refractory multiple myeloma patients treated with
carfilzomib-lenalidomide-dexamethasone combination chemotherapy
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2022
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Dong-A University Hospital
Agency class:
Other
Collaborator:
Agency:
Amgen
Agency class:
Industry
Source:
Dong-A University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495620
