ASA vs. Rivaroxaban in Newly Diagnosed or Relapsed and Refractory Multiple Myeloma Patients Treated With Len-Dex Combination Therapy.

Titre officiel

Rivaroxaban for Improvement of Thromboembolism Outcomes in Patients With Multiple Myeloma on Lenalidomide-based Therapy: RithMM Trial

Sommaire:

L’étude pilote envisagée est conçue comme un essai clinique multicentrique comparatif et randomisé, comparant l’impact de deux traitements différents, dont l’ASA et le rivaroxaban, chez des patients atteints d’un myélome multiple de diagnostic récent ou récidivant et réfractaire traité par un traitement combinant lénalidomide et dexaméthasone (Len-Dex)

Description de l'essai

Primary Outcome:

  • Thrombosis assessment of patients with Multiple Myeloma placed on the Rivaroxaban vs Aspirin
Secondary Outcome:
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The investigators will perform a pragmatic multicentre open label pilot randomized controlled trial in Canada (London, Hamilton, Ottawa, Halifax, Winnipeg ) to assess the feasibility of a full RCT to compare the efficacy and safety of Rivaroxaban or ASA in preventing venous or arterial thromboembolic events in patients with myeloma on Len-Dex based therapy. For the data collection the research team will use REDCap which is a Research Electronic Data Capture web-based tool for creating and managing online database applications and surveys. System will allow performing the randomization as well. Patients will be randomized to ASA 81 mg daily or Rivaroxaban 10 mg daily. Patients will enter the study at the time of commencement of anticoagulants (Rvaroxaban or ASA) and be followed for 6 months, or until 4 weeks after stopping Len-Dex, or they withdraw from the study, or they leave the province, or die, whichever comes first. Patients will be randomly assigned, in a 1: 1 ratio, to receive either Rivaroxaban 10 mg daily for 6 months or ASA 81 mg daily for 6 months. A web-based randomization system will ensure allocation concealment. Randomization will be stratified by site and by line of therapy (first line or other) in blocks of 4. Using a vanguard design, the research team intends to rollover the participants of our feasibility study into a full randomized control trial comparing the efficacy and safety of Rivaroxaban or ASA in preventing venous or arterial thromboembolic events (ATE) in myeloma patients receiving Len-Dex therapy. For the full RCT, the investigators plan to externally validate the IMWG criteria model for thromboembolic risk. The investigators will also evaluate the impact of adding myeloma bio-markers to the IMWG criteria to assess their association with TE risk and potentially improve the utility and generalizability of the IMWG criteria. The bio-markers are: D-dimer, LDH, B2 microglobulin and C-reactive protein (CRP). All of the IMWG criteria risk factors and the bio-markers will be collected for the participants of the feasibility study for potential future enrollment into the full RCT.

Voir cet essai sur ClinicalTrials.gov

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