Matches in SemOpenAlex for { <https://semopenalex.org/work/W2246453267> ?p ?o ?g. }
Showing items 1 to 78 of
78
with 100 items per page.
- W2246453267 endingPage "8015" @default.
- W2246453267 startingPage "8015" @default.
- W2246453267 abstract "8015 Background: The introduction of new drugs questions the role of autologous transplantation upfront. We compared MPR with tandem MEL200 in newly diagnosed pts. Methods: All pts (N=402) received four 28-day cycles of lenalidomide (25 mg d 1-21) and low-dose dexamethasone (40 mg d 1,8,15,22) (Rd) as induction. Cyclophosphamide plus G-CSF was used to mobilize stem cells. As consolidation, pts (N=202) were randomized to MPR [six 28-day cycles of melphalan (0.18 mg/kg d 1-4), prednisone (2 mg/kg d 1-4) and lenalidomide (10 mg d 1-21); pts (N=200)] or MEL200 [tandem melphalan 200 mg/m2 with stem-cell support]. Primary end point was PFS. Assuming the HR (MPR vs MEL200) of 1.15 (1-b 80%, 2 side a .05), the sample size was 380 (190/190). Results: The median age was 58 years in both groups. After Rd induction, at least partial response (PR) was 83%, at least very good partial response (VGPR) was 34%, including 6% complete remission (CR). The median yields of CD34+ cells harvested was 8.85x106 CD34+ cells/Kg; 94% of patients collected the minimum dose of 2x106/kg CD34+ cells. In a substudy, pts at diagnosis were also randomize to receive aspirin or LMWH as thrombo-prophylaxis, incidence of DVT was 3,5% and 2% (p= 0.6), respectively. Induction with Rd was well tolerated: grade 3-4 adverse events were <10%. Pts who completed at least 3 MPR and 1 MEL200 were evaluated. After a median follow-up of 12 months, response rate, PFS and OS were similar in the two groups (see table). Consolidation with MEL200 resulted in a higher incidence of grade 3-4 adverse events (see table). Conclusions: Our study confirm the efficacy and safety of Rd induction. Both MPR and MEL200 improved the quality of response, achieved by Rd induction. At present, PFS and OS are not significantly different in the two groups. Clinical outcome after consolidation MPR MEL200 P value CR 14% 25% 0.19 ≥VGPR 57% 62% 0.24 PFS @ 12 months 91% 91% 0.77 OS @ 12 months 97% 98% 0.27 G3-4 hematologic toxicity 45% 86% 0.001 Neutropenia 8% 87% 0.001 Thrombocytopenia G3-4 Extra-hematologic toxicity Infections 0% 15% 0.001 Gastrointestinal 0% 23% 0.001 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene Celgene Celgene" @default.
- W2246453267 created "2016-06-24" @default.
- W2246453267 creator A5007558343 @default.
- W2246453267 creator A5017728103 @default.
- W2246453267 creator A5018139001 @default.
- W2246453267 creator A5018139570 @default.
- W2246453267 creator A5020369336 @default.
- W2246453267 creator A5034587847 @default.
- W2246453267 creator A5059967673 @default.
- W2246453267 creator A5064302985 @default.
- W2246453267 creator A5068769311 @default.
- W2246453267 creator A5083973342 @default.
- W2246453267 date "2010-05-20" @default.
- W2246453267 modified "2023-10-18" @default.
- W2246453267 title "A phase III trial of melphalan/prednisone/lenalidomide (MPR) versus melphalan (200 mg/m2) and autologous transplantation (MEL200) in newly diagnosed myeloma patients." @default.
- W2246453267 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.8015" @default.
- W2246453267 hasPublicationYear "2010" @default.
- W2246453267 type Work @default.
- W2246453267 sameAs 2246453267 @default.
- W2246453267 citedByCount "5" @default.
- W2246453267 countsByYear W22464532672012 @default.
- W2246453267 countsByYear W22464532672016 @default.
- W2246453267 crossrefType "journal-article" @default.
- W2246453267 hasAuthorship W2246453267A5007558343 @default.
- W2246453267 hasAuthorship W2246453267A5017728103 @default.
- W2246453267 hasAuthorship W2246453267A5018139001 @default.
- W2246453267 hasAuthorship W2246453267A5018139570 @default.
- W2246453267 hasAuthorship W2246453267A5020369336 @default.
- W2246453267 hasAuthorship W2246453267A5034587847 @default.
- W2246453267 hasAuthorship W2246453267A5059967673 @default.
- W2246453267 hasAuthorship W2246453267A5064302985 @default.
- W2246453267 hasAuthorship W2246453267A5068769311 @default.
- W2246453267 hasAuthorship W2246453267A5083973342 @default.
- W2246453267 hasConcept C126322002 @default.
- W2246453267 hasConcept C126894567 @default.
- W2246453267 hasConcept C141071460 @default.
- W2246453267 hasConcept C2776063141 @default.
- W2246453267 hasConcept C2776364478 @default.
- W2246453267 hasConcept C2776694085 @default.
- W2246453267 hasConcept C2776755627 @default.
- W2246453267 hasConcept C2777408962 @default.
- W2246453267 hasConcept C2778684742 @default.
- W2246453267 hasConcept C2911091166 @default.
- W2246453267 hasConcept C71924100 @default.
- W2246453267 hasConcept C90924648 @default.
- W2246453267 hasConceptScore W2246453267C126322002 @default.
- W2246453267 hasConceptScore W2246453267C126894567 @default.
- W2246453267 hasConceptScore W2246453267C141071460 @default.
- W2246453267 hasConceptScore W2246453267C2776063141 @default.
- W2246453267 hasConceptScore W2246453267C2776364478 @default.
- W2246453267 hasConceptScore W2246453267C2776694085 @default.
- W2246453267 hasConceptScore W2246453267C2776755627 @default.
- W2246453267 hasConceptScore W2246453267C2777408962 @default.
- W2246453267 hasConceptScore W2246453267C2778684742 @default.
- W2246453267 hasConceptScore W2246453267C2911091166 @default.
- W2246453267 hasConceptScore W2246453267C71924100 @default.
- W2246453267 hasConceptScore W2246453267C90924648 @default.
- W2246453267 hasIssue "15_suppl" @default.
- W2246453267 hasLocation W22464532671 @default.
- W2246453267 hasOpenAccess W2246453267 @default.
- W2246453267 hasPrimaryLocation W22464532671 @default.
- W2246453267 hasRelatedWork W2000847356 @default.
- W2246453267 hasRelatedWork W2022119793 @default.
- W2246453267 hasRelatedWork W2320724904 @default.
- W2246453267 hasRelatedWork W2353124159 @default.
- W2246453267 hasRelatedWork W2435256000 @default.
- W2246453267 hasRelatedWork W2594719251 @default.
- W2246453267 hasRelatedWork W2950846836 @default.
- W2246453267 hasRelatedWork W3024147820 @default.
- W2246453267 hasRelatedWork W3028603149 @default.
- W2246453267 hasRelatedWork W4225390146 @default.
- W2246453267 hasVolume "28" @default.
- W2246453267 isParatext "false" @default.
- W2246453267 isRetracted "false" @default.
- W2246453267 magId "2246453267" @default.
- W2246453267 workType "article" @default.