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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

RithMM Trial 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.Check my eligibility
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.See study design
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.

RithMM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Multiple Myeloma.
Select...
I am about to start treatment with Lenalidomide and Dexamethasone.
Select...
I am 18 years old or older.

RithMM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
1%
Hypertension
1%
Ovarian cyst
1%
Osteoarthritis
1%
Gastrointestinal hemorrhage
1%
Escherichia sepsis
1%
Joint arthroplasty
1%
Leiomyoma
1%
Syncope
1%
Asthma
1%
Hysterectomy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rivaroxaban
Aspirin

RithMM 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
51 Previous Clinical Trials
11,552 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,158 Total Patients Enrolled
1 Trials studying Multiple Myeloma
74 Patients Enrolled for Multiple Myeloma
Dalhousie UniversityOTHER
166 Previous Clinical Trials
403,056 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the required qualifications join this trial right now?

"This trial, which was first posted on 7/30/2023 is recruiting patients right now. The last update to the posting on clinicaltrials.gov was 10/3/2022"

Answered by AI

How many different people are included in this clinical trial?

"That is accurate. The clinicaltrials.gov website has information revealing that this trial is still recruiting patients. This particular study was originally posted on 7/30/2023 and was edited for the last time on 10/3/2022. They are looking to enroll 86 individuals from 1 location."

Answered by AI

Would this experiment be beneficial for elderly patients outside of the age limit?

"This study is looking for individuals over the age of 18 and younger than 90."

Answered by AI

Are there other examples in medical history of this type of experiment?

"There are 231 ongoing clinical trials testing the efficacy of Len-Dex+Rivaroxaban in 1585 cities and 64 countries. The first study began in 2002 and, after completing Phase 3 drug approval, 413 patients were involved. 710 studies have been conducted in the 18 years since the original trial."

Answered by AI

Could I take part in this experiment if I qualify?

"Candidates for this clinical trial must be between 18 and 90 years old and have a diagnosis of multiple myeloma. At the moment, there are approximately 86 potential participants needed."

Answered by AI

What are the common treatments that Len-Dex+Rivaroxaban help with?

"Len-Dex+Rivaroxaban can provide relief from pain, myocardial infarction, and catarrh."

Answered by AI
Recent research and studies
~9 spots leftby Mar 2025