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Central point: KRd joint transplants extended for NDMM patients provide high-quality relief, with extended disease control time and controlled tolerance, rapid remission, but most patients need extended KRd treatment if optimal remission is required.
Abstract: In the multi-center Phase II study (NCT01816971), researchers evaluated the efficacy of a combined Kafazomi-lysemisin (KRd) programme for newly diagnosed multiple myeloma (NDMM) patients.
patients with inhibited NDMM were recruited, and KRd-induced-ASCT-4 courses of KRd were consolidated in 4 courses, and KRd was maintained for 10 courses.
end point is a strict total remission (sCR) rate after 8 KRd sessions, with a predefined threshold of 50%.
a total of 76 patients participated in the trial, with a mid-age age of 59 years (40-76 years) and 35.5% of patients with high-risk cytogenetics.
the results of the study reached the main endpoint, with a sCR rate of 60% after eight sessions.
and the depth of relief deepens over time.
the sCR rate was 76% among people with intent therapy (ITT).
the corrected ITT, the MRD negative rate using second-generation sequencing was 70%. After 56 months of
's mid-level follow-up, the five-year progression-free survival rate (PFS) and overall survival rate (OS) in the ITT population were 72% and 84%, respectively, 85% and 91% in MRD-negative patients, 57% and 72% in high-risk cytogenetics, and 77% and 81% in MRD-negative patients, respectively.
3/4 adverse reactions included a decrease in neutral granulocytes (34%), a decrease in lymphocytes (32%), infection (22%) and cardiovascular events (3%).
no 3/4 peripheral neuropathy.
, NDMM patients treated with KRd combined ASCT were able to achieve higher sCR and MRD negative rates after KRd consolidation.
after solidating chemotherapy, prolonged KRd maintenance therapy can help deepen remission and may also prolong PFS and OS.
safety and tolerance are controlled.
.