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Patients with MM will receive Len-Dex combination and Rivaroxaban (10 mg) daily

Patients MM will receive Len-Dex combination and ASA 81 mg daily

Martha Louzada, MD

The intended study is designed as a a phase IV pragmatic multicenter randomized controlled clinical trial, comparing the impact of two different therapies including ASA vs. Rivaroxaban in newly diagnosed or relapsed and refractory multiple myeloma patients treated with Lenalidomide Dexamethasone (Len-Dex) combination therapy. The pilot feasibility study was conducted in preparation for this randomized controlled trial designed to assess the effect of an intervention.

RithMM is a phase IV, pragmatic, multicenter, open label Canadian trial. The study started with a pilot feasibility phase where 3 centres (London, Ottawa and Halifax) enrolled 34 patients within 12 months. Utilizing a roll-over design, the full RithMM trial will require a total of 304 patients to demonstrate that rivaroxaban 10 mg daily for 6 months is superior to ASA 81 mg daily for 6 months in preventing any thromboembolic events in newly diagnosed myeloma (NDMM) and relapsed/refractory (RRMM) patients on Len-Dex -based therapy. The study will require 8 participating centres in order to be able to achieve our recruitment goal within 12 to 18 months. Patients with NDMM or RRMM receiving Len-Dex based combination therapy with or without combination with other anti-myeloma drugs will be assessed for eligibility to be enrolled in the study. The research team intends to rollover the participants of our feasibility study into this current full randomized control trial comparing the efficacy outcome for the RithMM trial is the overall incidence of cardiovascular events, which includes arterial or venous thromboembolic events.

By conducting this trial, the investigators plan to externally validate the International Myeloma Working Group (IMWG) criteria model for thromboembolic risk by assessing the relevance of measuring pre-specified myeloma and thrombosis activity biomarkers (D-Dimer, beta-2 microglobulin, C-reactive protein (CRP), LDH) at every follow-up visit and their potential association with thromboembolism (TE) risk.

Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma

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

At each visit, patients will be asked standardized questions to capture the presence of primary. During these interviews the study coordinator will collect data related to resource utilization (e.g. health care services use) and ask whether the patient had a diagnosis of VTE, ATE or a bleeding event during this period. Any hospital or medical office encounters associated to any of the above-mentioned complaints will be checked and any test or procedures done will be recorded (e.g; echocardiogram, ECG, CT scan, MRI, transfusion).

Frequency and severity of adverse events and serious AEs based on hospital admission and patient-self reporting events

Subgroup analysis stratifying patients into low and high risk of thromboembolic events to assess any potential difference in the efficacy and safety outcomes.

The bio-markers are: D-dimer, LDH, B2 microglobulin and C-reactive protein (CRP) will be collected

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma	NCT03428373	Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom...	Rivaroxaban ASA	18 Years - 90 Years	Lawson Health Research Institute
Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma	NCT03428373	Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom...	Rivaroxaban ASA	18 Years - 90 Years	Lawson Health Research Institute

Spots Global Cancer Trial Database for multiple myeloma stage ii