title: MELISSE, a large multicentric observational study to determine risk factors of venous thromboembolism in patients with multiple myeloma treated with immunomodulatory drugs.
abstract: Immunomodulatory drugs (IMiDs) are associated with an increased risk of venous thromboembolism (VTE) in multiple myeloma (MM) patients. We designed MELISSE, a multicentre prospective observational study, to evaluate VTE incidence and identify risk factors in IMiDs-treated MM. Our objective was to determine the real-life practice of VTE prophylaxis strategy. A total of 524 MM patients were included, and we planned to collect information at baseline, at four and at 12 months, on MM therapy, on VTE risk factors and management. VTE incidence was 7% (n=31), including 2.5% pulmonary embolism (PE) (n=11), similar at four or 12 months. VTE was observed at all risk assessment levels, although the increased risk assessment level correlated to a lower rate of VTE, maybe due to the implemented thromboprophylaxis strategy. VTE occurred in 7% on aspirin vs 3% on low-molecular-weight heparin (LMWH) prophylaxis, and none on vitamin K antagonists (VKA). New risk factors for VTE in IMiDs-treated MM were identified. In conclusion, VTE prophylaxis is compulsory in IMiDs-treated MM, based on individualised VTE risk assessment. Anticoagulation prophylaxis with LMWH should clearly be prioritised in MM patients with high VTE risk, along with VKA. Further prospective studies will identify most relevant VTE risk factors in IMiDs-treated MM to select accurately which MM patients should receive LMWH prophylaxis and for which duration to optimise VTE risk reduction.
authors.affiliation: Xavier Leleu, MD, PhD, Service des Maladies du Sang, Hôpital Huriez, CHRU Lille, Rue Michel Polonovski, 59037 Lille cedex, France, Tel : + 33 3 20 44 68 83, Fax: + 33 3 20 44 40 94, E-mail: xavier.leleu@chru-lille.fr.
authors.forename: Xavier
authors.initials: X
authors.lastname: Leleu
authors.forename: Philippe
authors.initials: P
authors.lastname: Rodon
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Laurent
authors.initials: L
authors.lastname: Daley
authors.forename: Charles
authors.initials: C
authors.lastname: Dauriac
authors.forename: Maya
authors.initials: M
authors.lastname: Hacini
authors.forename: Olivier
authors.initials: O
authors.lastname: Decaux
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Eisemann
authors.forename: Olivier
authors.initials: O
authors.lastname: Fitoussi
authors.forename: Bruno
authors.initials: B
authors.lastname: Lioure
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Borhane
authors.initials: B
authors.lastname: Slama
authors.forename: Ahmad
authors.initials: A
authors.lastname: Al Jijakli
authors.forename: Riad
authors.initials: R
authors.lastname: Benramdane
authors.forename: Carinne
authors.initials: C
authors.lastname: Chaleteix
authors.forename: Régis
authors.initials: R
authors.lastname: Costello
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.forename: Claire
authors.initials: C
authors.lastname: Mathiot
authors.forename: Eileen
authors.initials: E
authors.lastname: Boyle
authors.forename: Frédéric
authors.initials: F
authors.lastname: Maloisel
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Stoppa
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kolb
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Anne
authors.initials: A
authors.lastname: Lamblin
authors.forename: Patrick
authors.initials: P
authors.lastname: Natta
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Ismail
authors.initials: I
authors.lastname: Elalamy
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Fermand
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000209:etiology / Q000517:prevention & control*
chemical_list: D005343:Fibrinolytic Agents; D007155:Immunologic Factors
keywords: Myeloma; deep venous thrombosis; immunomodulatory drugs; risk factors