NCT01093196: Phase 3: EMN01- Len/Dex Vs Melphalan/Pred/Len Vs Cyclophosamide/Pred/Len - elderly NDMM

EMN01

European Myeloma Network

Newly Diagnosed Multiple Myeloma

NCT01093196: Phase 3: Len and Dex Vs Melphalan Prednisone and Len Vs Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients

NCT01093196: Phase 3: Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients

This is a multicenter, randomized, controlled, 3 arm parallel group study designed to evaluate the efficacy and safety of three all-oral combinations: lenalidomide with dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed symptomatic MM patients. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study.

Sponsor

Fondazione EMN Italy Onlus

Home - European Myeloma Network (myeloma-europe.org)

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ClinicalTrials.gov Identifier: NCT01093196

Official Title: A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, Prednisone and Lenalidomide (CPR) in Newly Diagnosed Elderly Multiple Myeloma Subjects

First Posted : March 25, 2010

Click here for details on ClinicalTrials.gov

EMN01 - European Myeloma Network (myeloma-europe.org)

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Drug: Melphalan, Prednisone, Lenalidomide

Drug: Cyclophosphamide, Prednisone, Lenalidomide

Drug: Lenalidomide, dexamethasone

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Blood; 2015

Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report

https://pubmed.ncbi.nlm.nih.gov/25628469/

Click here to read details

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Blood;2016

Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma

https://pubmed.ncbi.nlm.nih.gov/26729895/

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Haematologica; 2020

Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial

https://pubmed.ncbi.nlm.nih.gov/31582542/

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Haematologica; 2020

Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs

https://pubmed.ncbi.nlm.nih.gov/31221778/

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MYELOMA FRAILTY SCORE CALCULATOR

http://www.myelomafrailtyscorecalculator.net/