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Rivaroxaban vs Aspirin for Multiple Myeloma (RithMM Trial)

Phase 2 & 3
Waitlist Available
Led By Martha Louzada, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Diagnosis of Multiple Myeloma
Must not have
Uncontrolled or poorly controlled diabetes or renal disease
Major bleeding event within the previous 3 months prior to commencement of Len Dex therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will compare the effects of two different therapies, ASA vs. Rivaroxaban, in newly diagnosed or relapsed and refractory multiple myeloma patients treated with Len-Dex combination therapy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Rivaroxaban may cause bleeding complications, digestive issues or allergic reactions. Aspirin could lead to stomach ulcers, increased bleeding risk especially if taken at high doses over long periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Multiple Myeloma.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes or kidney disease is not well-managed.
Select...
I have not had a major bleeding event in the last 3 months.
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I am taking medication to prevent blood clots due to a heart or neck artery stent.
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I am currently taking lenalidomide as my only treatment.
Select...
I am not willing or able to agree to join the study.
Select...
I have not had major surgery in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of venous thromboembolic (VTE) and/or arterial thromboembolic (ATE) events in patients with Multiple Myeloma placed on the Rivaroxaban vs Aspirin after starting with Len-Dex therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Secondary study objectives
Assessment of correlation of between levels of biomarkers of myeloma and thrombosis with the risk of ATE or VTE
Multiple Myeloma

Side effects data

From 2020 Phase 3 trial • 179 Patients • NCT02164578
2%
Hypertensive crisis
1%
Diverticulitis
1%
Chest pain
1%
Bile duct stone
1%
Cerebrovascular accident
1%
Nausea
1%
Foot fracture
1%
Erysipelas
1%
Vomiting
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin
Rivaroxaban

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Len-Dex+RivaroxabanExperimental Treatment1 Intervention
Patients with MM will receive Len-Dex combination and Rivaroxaban (10 mg) daily
Group II: Len-Dex+ASAActive Control1 Intervention
Patients MM will receive Len-Dex combination and ASA 81 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved

Find a Location

Who is running the clinical trial?

St. Boniface HospitalOTHER
54 Previous Clinical Trials
14,977 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,283 Total Patients Enrolled
1 Trials studying Multiple Myeloma
74 Patients Enrolled for Multiple Myeloma
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,797 Total Patients Enrolled
Niagara Health SystemOTHER
7 Previous Clinical Trials
2,587 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
339,872 Total Patients Enrolled
1 Trials studying Multiple Myeloma
60 Patients Enrolled for Multiple Myeloma
The Ottawa HospitalOTHER
94 Previous Clinical Trials
63,699 Total Patients Enrolled
Martha Louzada, MDPrincipal InvestigatorLawson Health Research Institute

Media Library

Len-Dex+Rivaroxaban Clinical Trial Eligibility Overview. Trial Name: NCT03428373 — Phase 2 & 3
Multiple Myeloma Research Study Groups: Len-Dex+ASA, Len-Dex+Rivaroxaban
Multiple Myeloma Clinical Trial 2023: Len-Dex+Rivaroxaban Highlights & Side Effects. Trial Name: NCT03428373 — Phase 2 & 3
Len-Dex+Rivaroxaban 2023 Treatment Timeline for Medical Study. Trial Name: NCT03428373 — Phase 2 & 3
~8 spots leftby Dec 2025
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