The purpose of this study is to evaluate the evaluate the efficacy and safety of administering a combination of carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or advanced multiple myeloma after carfilzomib, lenalidomide, and dexamethasone therapy.
This study is a phase 2 study in which patients with RRMM under 80 years of age who have been treated with lenalidomide monotherapy for at least 6 months after KRd combination therapy will receive carfilzomib, pomalidomide, and dexamethasone combination therapy. A total of 33 participants are recruited. KPd will be administered until progressive disease or unacceptable toxicities. Participants who discontinued treatment will be followed up for disease status and survival at 2-month intervals. Responses are assessed using the International Myeloma Working Group (IMWG) response criteria and the safety profile is described using NCI-CTCAE v5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Carfilzomib 56 mg/m2 (Day1, 8, 15) (Cycle1 Day1, 20 mg/m2)
Pomalidomide 4 mg per os (Day1-21)
Dexamethasone 40 mg (D1, 8, 15, 22) (20 mg for patients ≥ 75 years old)
Samsung Medical Center
Seoul, South Korea
RECRUITINGOverall response rate
percentage of patients who achieve at least partial response
Time frame: assessed for approximately 3 years after administration
Complete response rate
percentage of patients who achieve complete response
Time frame: assessed for approximately 3 years after administration
Progression free survival rate
percentage of patients who are disease free or alive
Time frame: assessed for approximately 3 years after administration
Overall survival
from the time of written consent to the time of death or last follow-up
Time frame: assessed for approximately 3 years after administration
Duration of response
from the time of achieving at least partial response to the time of progressive disease
Time frame: assessed for approximately 3 years after administration
Time to response
from the time of written consent to the time of achieving at least partial response
Time frame: assessed for approximately 3 years after administration
Incidence of treatment-emergent adverse events
Safety profiles of carfilzomib, pomalidomide, and dexamethasone for myeloma patients who had relapsed or progressed
Time frame: assessed for approximately 3 years after administration
Minimal residual disease negativity
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The specimen is bone marrow aspirate, and it should be free of clonal plasma cells by examination by the NGF (next-generation flow) method. At this time, the test should be performed according to the EuroFlow standard operation procedure for MRD detection in MM, and the minimum sensitivity should be10 to the 5th power or higher.
Time frame: up to 3 years