Challenges of Conducting a Feasibility Pilot Randomized Controlled Trial During COVID-19 Restrictions: Rivaroxaban Versus Acetyl Salicylic Acid in Patients with Multiple Myeloma on Lenalidomide-Based Therapy (RithMM).
Matthew Strelau, Gregoire Le Gal, Arleigh McCurdy et al.
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In 30 seconds
This multicentre pilot randomised controlled trial assessed whether a full-scale comparison of rivaroxaban and acetylsalicylic acid for thromboprophylaxis was feasible in patients with multiple myeloma receiving lenalidomide-based therapy. Fifty-five patients were recruited across three Canadian centres and assigned to low-dose acetylsalicylic acid or rivaroxaban, with bleeding and thrombotic events monitored during lenalidomide-dexamethasone treatment. Two venous thromboembolic events and two bleeding events occurred; all four were in the acetylsalicylic acid arm. The study did not meet its predefined feasibility goals, but the authors concluded that a full-scale trial remains feasible.
Key findings
- Fifty-five patients were recruited across three Canadian centres.
- Two venous thromboembolic events and two bleeding events occurred, all in the acetylsalicylic acid arm.
- Predefined feasibility goals were not achieved; a post hoc analysis used active recruitment time to assess recruitment feasibility.
Why it matters
Thromboprophylaxis is relevant because venous thromboembolism is a serious complication in multiple myeloma, particularly during combination treatment. This pilot provides preliminary event observations and information about recruitment challenges for a direct comparison of rivaroxaban with acetylsalicylic acid. Its small scale and feasibility focus mean the event counts do not establish comparative efficacy or safety.
What to keep in mind
This was a pilot that did not meet its predefined feasibility goals; only 55 patients were recruited, and the reported event counts are too limited to establish comparative efficacy or safety.