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The introduction of immunomodulating agents, protease inhibitors and autologic hematopoietic stem cell transplantation improved the prognosis of patients with multiple myeloma, but the long-term prognosis of patients with high-risk multiple myeloma was still poor.
study aims to explore the best treatment options for this type of patient.
SWOG-1211 was a randomized Phase 2 trial in which the subjects were randomly divided into two groups to receive the same course of induction therapy with or without elotuzumab (Erottoju monoanti) to maintain treatment at the same dose reduction until the disease progressed.
high-risk multiple myeloma: carrying high risk (GEPhi), t (14; 16)、t(14; 20), del (17p) or amp1q21, primary plasma cell leukemia or serum lactic acid dehydrogenase elevated (more than 2 times the normal upper limit).
end point is no progress.
October 27, 2013 - May 15, 2016, a total of 100 patients were recruited (52 in the RVd group and 48 in the RVd-Elotumab group).
age of 64 (IQR 57-70, range 36-85).
74 (75%) of the 99 patients were in Phase II or III, 47 (47%) carried amp1q21, 37 (37%) carried del17p, and 11 (11%) carried t (14; 16), 8 bits (9%) for GEPhi, 7 bits (7%) for primary plasma cell leukemia, 5 bits (5%) with t (14; 20), 4 bits (4%) serum lactic acid dehydrogenase elevated.
53 months (IQR46-59), the difference in the non-progression lifetime of the two groups was not statistically significant (RVd group 33.64 months (95% CI 19.55-not reached), RVd-Elotuzum Ab group 31.47 months ( 18.56-53.98 ) ; risk ratio 0.968 ( 80% CI 0.697-1.344 ) ; one-sided p .
(71%) of the 52 patients in the RVd group and 37 of the 48 patients in the RVd-Elotuzumab group (77%) had level 3 or more adverse events.
differences were not observed between the two groups of adverse reaction events.
deaths in the RVd group and one death in the RVd-Elotuzumab group.
the study, the first randomized study of high-risk multiple myeloma, showed that adding Elotuzumab to RVd induction and maintenance did not improve the prognosis of patients.
, however, the non-progressive survival rate of both study groups exceeded the initial statistical assumptions and supported the therapeutic effect of continuous protease inhibitors and immunomodulative drug combination maintenance therapy on this group of patients.