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).
4 affiliations
- 1Division of Hematology, Department of Oncology, London Health Sciences Centre, University of Western Ontario, London, ON N6A 5W9, Canada.
- 2Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON K1H 8L6, Canada.
- 3Department of Medicine, Dalhousie University, Nova Scotia Health Authority, Halifax, NS B3H 4R2, Canada.
- 4Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON N6A 3K7, Canada.
Abstract
Venous thromboembolism is a serious medical complication with an increased risk in patients with multiple myeloma undergoing combination treatment regimens. Acetylsalicylic acid is routinely used as a method of thromboprophylaxis in multiple myeloma patients treated with lenalidomide, and rivaroxaban has been assessed in small-scale studies in multiple myeloma patients treated with immunomodulatory drugs; yet, no study has compared the two methods. In this pilot, we asked if a full-scale trial would be feasible to assess the benefits of rivaroxaban over acetylsalicylic acid as a thromboprophylactic approach. This pilot recruited patients with multiple myeloma on lenalidomide-based therapy and randomized them to either low-dose acetylsalicylic acid or rivaroxaban, then monitored bleeding and thrombotic events throughout lenalidomide-dexamethasone treatment. A total of 55 patients were recruited across three Canadian centres, with two venous thromboembolic events and two bleeding events, all in the acetylsalicylic acid arm. We conducted a post hoc analysis of active recruitment time as a definition of recruitment feasibility, as we did not achieve our pre-defined feasibility goals. Despite the challenges in enrollment, possibly due to social restrictions during the COVID-19 pandemic, we maintain that a full-scale trial is feasible and offers insight into thromboprophylactic management in this population.
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BibTeX
@article{strelau2026challenges,
title = {{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).}},
author = {Matthew Strelau and Gregoire Le Gal and Arleigh McCurdy and Sudeep Shivakumar and Jared C Wootten and Maisam Abouzeenni and Chai W Phua and Selay Lam and Alejandro Lazo-Langner and Mohamed Y Abouzeenni and Martha Louzada},
journal = {Current oncology (Toronto, Ont.)},
year = {2026},
month = oct,
doi = {10.3390/curroncol33100633},
url = {https://europepmc.org/article/MED/42930200},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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).
AU - Matthew Strelau
AU - Gregoire Le Gal
AU - Arleigh McCurdy
AU - Sudeep Shivakumar
AU - Jared C Wootten
AU - Maisam Abouzeenni
AU - Chai W Phua
AU - Selay Lam
AU - Alejandro Lazo-Langner
AU - Mohamed Y Abouzeenni
AU - Martha Louzada
PY - 2026
DA - 2026/10/20
JO - Current oncology (Toronto, Ont.)
DO - 10.3390/curroncol33100633
UR - https://europepmc.org/article/MED/42930200
AB - Venous thromboembolism is a serious medical complication with an increased risk in patients with multiple myeloma undergoing combination treatment regimens. Acetylsalicylic acid is routinely used as a method of thromboprophylaxis in multiple myeloma patients treated with lenalidomide, and rivaroxaban has been assessed in small-scale studies in multiple myeloma patients treated with immunomodulatory drugs; yet, no study has compared the two methods. In this pilot, we asked if a full-scale trial would be feasible to assess the benefits of rivaroxaban over acetylsalicylic acid as a thromboprophylactic approach. This pilot recruited patients with multiple myeloma on lenalidomide-based therapy and randomized them to either low-dose acetylsalicylic acid or rivaroxaban, then monitored bleeding and thrombotic events throughout lenalidomide-dexamethasone treatment. A total of 55 patients were recruited across three Canadian centres, with two venous thromboembolic events and two bleeding events, all in the acetylsalicylic acid arm. We conducted a post hoc analysis of active recruitment time as a definition of recruitment feasibility, as we did not achieve our pre-defined feasibility goals. Despite the challenges in enrollment, possibly due to social restrictions during the COVID-19 pandemic, we maintain that a full-scale trial is feasible and offers insight into thromboprophylactic management in this population.
SN - 1198-0052
SN - 1718-7729
ER -