Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of Multiple Myeloma.
  • - Scheduled to start on Len-Dex therapy.
  • - Be ≥ 18 years of age.
  • - 4.
Pre-clinical laboratory must meet the following criteria at enrollment. 1. Platelet count >50 × 109/L. 2. AST <2.5x ULN. 3. ALT <2.5x ULN. 4. Total Bilirubin <2.0 xULN. 5. Creatinine clearance (CrCl) >15mL/min using Cockcroft-Gault Equation.
  • - Able to provide written informed consent.

Exclusion Criteria:

1. Major bleeding event within the previous 3 months prior to commencement of Len Dex therapy. 2. 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. 3. Patient with history of gastric or duodenal ulcer within 2 years. 4. 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. 5. Patient on antiplatelet agents due to an absolute indication (e.g.; coronary stent, carotid stent). 6. Patient on single agent lenalidomide. 7. Life expectancy less than 3 months as determined by the investigator. 8. Unstable medical or psychological condition that would interfere with trial participation, as determined by the investigator. 9. Patient not able or not willing to give consent to participate in the study. 10. Uncontrolled cardiovascular disease within 6 months prior to enrollment. 11. Uncontrolled or poorly controlled diabetes or renal disease. 12. Major surgery within 2 weeks before randomization. 13. Known allergies, hypersensitivity, or intolerance to any of the study drugs

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03428373
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lawson Health Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martha Louzada, MD
Principal Investigator Affiliation Lawson Health Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma in Relapse, Multiple Myeloma Progression, Multiple Myeloma Stage II, Multiple Myeloma Stage I, Multiple Myeloma With Failed Remission, Multiple Myeloma Stage III
Additional Details

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.

Arms & Interventions

Arms

Experimental: Len-Dex+Rivaroxaban

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

Active Comparator: Len-Dex+ASA

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

Interventions

Drug: - Rivaroxaban

Rivaroxaban 10mg daily

Drug: - ASA

ASA 81mg

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London Health Sciences Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre

London, Ontario, N6A 5W9

Site Contact

Maisam Abouzeenni

maisam.abouzeenni@lhsc.on.ca

5196858500 #56840