46 Patents wth relapsed or refractory MM and ?three prevous regmens have been elgble.Based othe fndngs of phase and studes, lenaldomde was admnstered at 25 mg day odays 1 21 of every 28 day cycle.Patents were randomzed to ether four 28 day cycles of lenaldomde plushgh dose dexamethasone forty mg day odays 1 four, 9 12, and 17 twenty of each cycle, or matched placebo plus dexamethasone as to the grouassgned to actve treatment method.Immediately after four cycles of treatment, treatment was contnued unt dsease progresson, but wth dexamethasone forty mg admnstered only odays 1 4 of every 28 day cycle.The prmary end pont of TTwas evaluated accordng to EBMT crtera.four A complete of 353 patents MM 009 and 351 patents MM 010 were randomzed and receved study medcaton.
Response prices and duratoof response Lenaldomde selleck plus dexamethasone the MM 009 and MM 010 studes, lenaldomde combnatowthhgh dose dexamethasone led to a sgnf cantly improved ORR in contrast wth dexamethasone alone.2,3 these studes, 108 patents MM 009 and 106 patents MM 010 assgned to lenaldomde plus dexamethasone acheved a response of PR or considerably better.comparson, 35 patents MM 009 and 42 patents MM 010 assgned to dexamethasone alonehad a response to treatment.each studes, the CR charge response to lenaldomde plus dexamethasone was approxmately 15% and also the nCR fee was approxmately 9%.two,three a pooled analyss that ncluded information from all 704 patents enrolled the two trals, the ORR the lenaldo mde plus dexamethasone grouand the dexamethasone only grouwas 60.6% and 21.9%, respectvely.97 The respectve information for CR charge have been 15.0% and 2.0%.
Among patents who receved lenaldomde plus dexamethasone, the medaduratoof response was sgnfcantlyhgher for anyone selelck kinase inhibitor who acheved a CR or nCR in contrast wth those who acheved a PR.98 Patents the MM 009 and MM 010 studes have been stratfed accordng to two mcroglobuln, pror SCT, and variety of pror regmens.2,three each studes lenaldomde plus dexamethasone
was assocated wth sgnfcantlyhgher response costs thadexamethasone alone, rrespectve of two mcroglobullevel, pror SCT, or number of pror therapes.addton, lenaldomde plus dexamethasoneeldedhgher response costs thadexamethasone alone rrespectve of pror bortezomb or thaldomde treatment.2,3 a prospectve, pooled subgrouanalyss of 704 patents enrolled the MM 009 and MM 010 studes, the ORR was sgnfcantlyhgher wth lenaldomde plus dexamethasone treatment method in contrast wth dexamethasone alone patents whohad receved pror thaldomde or patents whohad nothad pror thaldomde.99 Whepatents whohad receved pror thaldomde had been dvded nto 3 subgroups based othe degree of thaldomde resstance, the ORR was smar across resstance groups.