Rivaroxaban vs Aspirin for Multiple Myeloma

(RithMM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Martha Louzada, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Martha Louzada, MD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

Adults diagnosed with Multiple Myeloma starting Len-Dex therapy can join. They must have certain blood, liver, and kidney function levels and be able to consent. Excluded are those with recent major surgery or bleeding, uncontrolled diseases like diabetes or heart conditions, allergies to study drugs, on antiplatelet agents for specific reasons, or a life expectancy under 3 months.

Inclusion Criteria

Pre-clinical laboratory must meet the following criteria at enrollment: Platelet count >50 × 10^9/L, AST <2.5x ULN, ALT <2.5x ULN, Total Bilirubin <2.0 xULN, Creatinine clearance (CrCl) >15mL/min using Cockcroft-Gault Equation, Able to provide written informed consent

I have been diagnosed with Multiple Myeloma.

I am about to start treatment with Lenalidomide and Dexamethasone.

Exclusion Criteria

I am on blood thinners for clotting issues or to prevent stroke due to irregular heartbeat.

The doctor thinks you may live for less than 3 months.

I have not had uncontrolled heart problems in the last 6 months.

Treatment Details

Interventions

• ASA (Antiplatelet Agent)
• Rivaroxaban (Anticoagulant)

Trial Overview The trial compares Rivaroxaban (a blood thinner) versus ASA (Aspirin) in preventing blood clots in patients with Multiple Myeloma who are receiving Lenalidomide Dexamethasone treatment. It's a phase IV study where participants are randomly assigned to one of the two drugs.

Participant Groups

Group I: Len-Dex+Rivaroxaban Experimental Treatment 1 Intervention

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

Group II: Len-Dex+ASA Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lisa Porter

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Roy Butler

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

MD, PhD

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Dr. Alex Barron

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Executive Officer

Physiotherapy degree

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

St. Boniface Hospital

Collaborator

Trials

55

Recruited

15,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Dr. David Berd

Dalhousie University

Chief Medical Officer since 2020

MD

Dr. Kim Brooks

Dalhousie University

Chief Executive Officer since 2023

PhD in Tax Law

Niagara Health System

Collaborator

Trials

9

Recruited

2,800+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+