UNASSIGNED: The combination of @entity3601 , @entity229 and @entity2816 (MPT) is considered standard therapy for newly diagnosed @entity1 with @entity1582 (NDMM) who are ineligible for stem-cell transplantation. Long term treatment with @entity2816 is hampered by @entity2359 . @entity3601 , @entity229 and @entity6985 , followed by @entity6985 maintenance therapy showed promising results, without severe @entity16 emerging. We randomly assigned 668 NDMM @entity1 , ineligible for stem-cell transplantation, between nine 4-weekly cycles of MPT followed by @entity2816 maintenance until disease progression or unacceptable @entity137 ( @entity1619 ) and the same MP regimen with @entity2816 being replaced by @entity6985 (MPR-R). This multicenter, open-label, randomised phase 3 trial was undertaken by HOVON and the NMSG. The primary endpoint was progression-free survival (PFS). The accrual for the study was completed in October 19, 2012. 318 @entity1 were randomly assigned to receive @entity1619 and 319 MPR-R. After a median follow up of 36 months PFS with @entity1619 was 20 months (95% CI 18-23 months) versus 23 months (95% CI 19-27 months) with MPR-R (HR 0.87 [0.72-1.04], p=0.12). Response rates were similar, with >= VGPR 47% and 45% respectively. @entity1503 was more pronounced with MPR-R, especially grade 3 and 4 @entity1398 : 64 versus 27%. Neuropathy >=  grade 3 was significantly higher in the @entity1619 arm; 16% versus 2% in MPR-R, resulting in a significant shorter duration of maintenance therapy (5 versus 17 months in MPR-R), irrespective of age. MPR-R has no advantage over @entity1619 concerning efficacy. The @entity137 profile differed with clinically significant @entity16 during @entity2816 maintenance versus myelosuppression with MPR.

@entity6985 plus @entity3601 and @entity229 , followed by @entity6985 maintenance versus @entity2816 plus XXXX and @entity229 , followed by @entity2816 maintenance; results of the randomised phase 3 HOVON 87/NMSG18 trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity1619 :: ('MESH:D015458', 'Disease') :: ['MPT-T'] @entity229 :: ('MESH:D011241', 'Chemical') :: ['prednisone'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neuropathy'] @entity2816 :: ('MESH:D013792', 'Chemical') :: ['thalidomide'] @entity3601 :: ('MESH:D008558', 'Chemical') :: ['melphalan', 'Melphalan'] @entity1582 :: ('MESH:D009101', 'Disease') :: ['multiple myeloma'] @entity1503 :: ('MESH:D006402', 'Disease') :: ['Hematological toxicity'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity6985 :: ('MESH:C467567', 'Chemical') :: ['lenalidomide'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity']
@entity3601 :: (MESH:D008558,Chemical) :: ['melphalan']
