Status:
ACTIVE_NOT_RECRUITING
Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
The Ottawa Hospital
Dalhousie University
Conditions:
Multiple Myeloma in Relapse
Multiple Myeloma Progression
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
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 diagno...
Detailed Description
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 mo...
Eligibility Criteria
Inclusion
- Diagnosis of Multiple Myeloma
- Scheduled to start on Len-Dex therapy
- Be ≥ 18 years of age
- Able to provide written informed consent
- Pre-clinical laboratory must meet the following criteria at enrollment
- Platelet count \>50 × 109/L
- Creatinine clearance (CrCl) \>15mL/min using Cockcroft-Gault Equation
Exclusion
- Major bleeding event within the previous 3 months prior to commencement of Len Dex therapy
- Documented severe liver disease in the past 6 months (eg. acute clinical hepatitis, chronic active hepatitis, or cirrhosis)
- Patient with a history of antiphospholipid syndrome especially if he/she is triple positive for lupus anticoagulant, anticardiolipin antibodies, and/or anti-b2 glycoprotein I antibodies.
- A history of malignancy (with the exception of MM) within 2 years before randomization or any previously diagnosed malignancy with evidence of residual disease. Patients with a history of basal cell or squamous carcinoma are not excluded.
- Patient with history of gastric or duodenal ulcer within 2 years
- Plasma cell leukemia; systemic amyloidosis
- Patient on therapeutic anticoagulation for treatment of VTE or ATE, or stroke prevention in non-valvular atrial fibrillation. Patients with a previous history of VTE who are not on any active anticoagulant therapy will not be excluded.
- Patient on antiplatelet agents due to an absolute indication (e.g.; coronary stent, carotid stent).
- Patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp such as ketoconazole, itraconazole, posaconazole or ritonavir)
- Patient on single agent lenalidomide
- Life expectancy less than 3 months as determined by the investigator.
- Unstable medical or psychological condition that would interfere with trial participation, as determined by the investigator
- Patient not able or not willing to give consent to participate in the study
- Uncontrolled cardiovascular disease within 6 months prior to enrollment
- Uncontrolled or poorly controlled diabetes or renal disease
- Major surgery within 2 weeks before randomization
- Known allergies, hypersensitivity, or intolerance to any of the study drugs.
- Patients not able or not willing to give consent to participate in the Study.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03428373
Start Date
January 17 2019
End Date
September 30 2024
Last Update
February 29 2024
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9