The purpose of this study is to evaluate the efficacy and safety of salvage treatment with carfilzomib/lenalidomide/dexamethasone (KRD) followed by 2nd autologous stem cell transplantation (ASCT) and lenalidomide maintenance in patients with relapsed myeloma after 1st ASCT.
This is a single-arm phase II study to assess the efficacy and safety of KRD followed by 2nd ASCT - lenalidomide maintenance for 18 months in patients with relapsed multiple myeloma after 1st ASCT who are 70 years of age or younger. A total of 58 participants will be recruited. As a re-induction therapy 6 cycles of KRD (K, 27mg/m2, D1,2,8,9,15,16; R, 25 mg, D1-21; D, 40mg weekly, every 28 days) will be administered. If a patient achieves at least partial response, 2nd ASCT + lenalidomide 10mg for 18 months will be proceeded. Study will be continued until disease progression, unacceptable toxicity, or completion of pre-planned schedule. Response will be assessed using the International Myeloma Working Group(IMWG) response criteria and the safety profiles will be described using the NCI-CTCAE v5.0. Participants who discontinue therapy will be followed every 3 months for 3 years if they are on subsequent treatment, disease-free or dead.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Lenalidomide maintenance after carfilzomib, lenalidomide, and dexamethasone re-induction followed by the 2nd ASCT.
Samsung Medical Center
Seoul, South Korea
RECRUITING2-year progression free survival rate
percentage of patients who are disease free or alive at 2-years
Time frame: 2-years after the written consent
Complete response rate after KRd #6
percentage of patients who achieve complete response
Time frame: total 6 cycles (each cycle is 28 days) of induction therapy
Complete response rate after ASCT
percentage of patients who achieve complete response
Time frame: at the time of 2nd ASCT (within 60 days after ASCT)
Overall response rate
percentage of patients who achieve at least partial response
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
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
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
Safety of KRd induction therapy, 2nd ASCT, and lenalidomide maintenance therapy
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treatment-emergent adverse events
Time frame: assessed for approximately 2 years during administration
Rate of the successful stem cell harvest
percentage of patients who collected cluster of differentiation(CD34+) hematopoietic stem cells \> 2 x 10\^6 cells/kg
Time frame: total 6 cycles (each cycle is 28 days) of induction therapy