Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma (RithMM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03428373 |
Recruitment Status :
Recruiting
First Posted : February 9, 2018
Last Update Posted : October 5, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma in Relapse Multiple Myeloma Progression Multiple Myeloma Stage II Multiple Myeloma Stage I Multiple Myeloma With Failed Remission Multiple Myeloma Stage III | Drug: Rivaroxaban Drug: ASA | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Rivaroxaban for Improvement of Thromboembolism Outcomes in Patients With Multiple Myeloma on Lenalidomide-based Therapy: RithMM Trial |
Estimated Study Start Date : | July 30, 2023 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | July 30, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Len-Dex+Rivaroxaban
Patients with MM will receive Len-Dex combination and Rivaroxaban (10 mg) daily
|
Drug: Rivaroxaban
Rivaroxaban 10mg daily
Other Name: Xarelto |
Active Comparator: Len-Dex+ASA
Patients MM will receive Len-Dex combination and ASA 81 mg daily
|
Drug: ASA
ASA 81mg
Other Name: aspirin |
- 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 [ Time Frame: 6 months ]At each visit, patients will be asked standardized questions to capture the presence of primary. During these interviews the study coordinator will collect data related to resource utilization (e.g. health care services use) and ask whether the patient had a diagnosis of VTE, ATE or a bleeding event during this period. Any hospital or medical office encounters associated to any of the above-mentioned complaints will be checked and any test or procedures done will be recorded (e.g; echocardiogram, ECG, CT scan, MRI, transfusion).
- Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 [ Time Frame: 6 months ]Frequency and severity of adverse events and serious AEs based on hospital admission and patient-self reporting events
- External validation of the IMWG criteria for risk assessment of thromboembolic events in multiple myeloma patients [ Time Frame: 6 months ]Subgroup analysis stratifying patients into low and high risk of thromboembolic events to assess any potential difference in the efficacy and safety outcomes.
- Assessment of correlation of between levels of biomarkers of myeloma and thrombosis with the risk of ATE or VTE [ Time Frame: 6 months ]The bio-markers are: D-dimer, LDH, B2 microglobulin and C-reactive protein (CRP) will be collected

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Platelet count >50 × 109/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
Exclusion Criteria:
- Major bleeding event within the previous 3 months prior to commencement of Len Dex therapy
- 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
- 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).
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428373
Contact: Martha Louzada, MD MSc (Epid) | 519-685-8500 ext 52391 | Martha.Louzada@lhsc.on.ca | |
Contact: Kate Kelly, MSc MPH/Gero | 519-685-8500 ext 53639 | kate.kelly@lhsc.on.ca |
Canada, Ontario | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: Maisam Abouzeenni 5196858500 ext 56840 maisam.abouzeenni@lhsc.on.ca | |
Contact: Terryl Angle 519-685-8500 ext 57135 terryl.angle@lhsc.on.ca |
Principal Investigator: | Martha Louzada, MD | Lawson Health Research Institute |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT03428373 |
Other Study ID Numbers: |
110804 |
First Posted: | February 9, 2018 Key Record Dates |
Last Update Posted: | October 5, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Rivaroxaban Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Anticoagulants |