ASA vs. Rivaroxaban in Newly Diagnosed or Relapsed and Refractory Multiple Myeloma Patients Treated With Len-Dex Combination Therapy. (RithMM)
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| ClinicalTrials.gov Identifier: NCT03428373 |
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Recruitment Status :
Recruiting
First Posted : February 9, 2018
Last Update Posted : March 10, 2020
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Sponsor:
Lawson Health Research Institute
Collaborators:
The Ottawa Hospital
Dalhousie University
St. Boniface Hospital
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Lawson Health Research Institute
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Brief Summary:
The intended pilot study is designed as a 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
| 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 |
The investigators will perform a pragmatic multicentre open label pilot randomized controlled trial in Canada (London, Hamilton, Ottawa, Halifax, Winnipeg ) to assess the feasibility of a full RCT to compare the efficacy and safety of Rivaroxaban or ASA in preventing venous or arterial thromboembolic events in patients with myeloma on Len-Dex based therapy. For the data collection the research team will use REDCap which is a Research Electronic Data Capture web-based tool for creating and managing online database applications and surveys. System will allow performing the randomization as well. Patients will be randomized to ASA 81 mg daily or Rivaroxaban 10 mg daily. Patients will enter the study at the time of commencement of anticoagulants (Rvaroxaban or ASA) and be followed for 6 months, or until 4 weeks after stopping Len-Dex, or they withdraw from the study, or they leave the province, or die, whichever comes first. Patients will be randomly assigned, in a 1: 1 ratio, to receive either Rivaroxaban 10 mg daily for 6 months or ASA 81 mg daily for 6 months. A web-based randomization system will ensure allocation concealment. Randomization will be stratified by site and by line of therapy (first line or other) in blocks of 4. Using a vanguard design, the research team intends to rollover the participants of our feasibility study into a full randomized control trial comparing the efficacy and safety of Rivaroxaban or ASA in preventing venous or arterial thromboembolic events (ATE) in myeloma patients receiving Len-Dex therapy. For the full RCT, the investigators plan to externally validate the IMWG criteria model for thromboembolic risk. The investigators will also evaluate the impact of adding myeloma bio-markers to the IMWG criteria to assess their association with TE risk and potentially improve the utility and generalizability of the IMWG criteria. The bio-markers are: D-dimer, LDH, B2 microglobulin and C-reactive protein (CRP). All of the IMWG criteria risk factors and the bio-markers will be collected for the participants of the feasibility study for potential future enrollment into the full RCT.
| 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 |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | March 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Rivaroxaban
| Arm | Intervention/treatment |
|---|---|
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Experimental: Len-Dex+Rivaroxaban
Patients with MM will receive Len-Dex combination and Rivaroxaban (10 mg) daily
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Drug: Rivaroxaban
Rivaroxaban 10mg daily
Other Name: Xarelto |
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Active Comparator: Len-Dex+ASA
Patients MM will receive Len-Dex combination and ASA 81 mg daily
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Drug: ASA
ASA 81mg
Other Name: aspirin |
Primary Outcome Measures :
- Thrombosis assessment of patients with Multiple Myeloma placed on the Rivaroxaban vs Aspirin [ Time Frame: 6 months ]Participants that develop symptoms of venous or arterial thromboembolism will be assessed as per standard of care such as Doppler ultrasound for deep venous thrombosis ad CTPA or V/Q lung scan for Pulmonary embolism; and appropriate cardiac interventions for coronary events.
Secondary Outcome Measures :
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]Frequency and severity of adverse events and serious AEs based on hospital admission and patientself reporting events
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients with NDMM or RRMM
- Must be receiving Len-Dex based treatment
Exclusion Criteria:
- Creatinine clearance (CrCl) is less than 15mL/min;
- Platelet count is less than 50,000;
- Patient with a history of antiphospholipid syndrome especially if he/she is triple positive for lupus anticoagulant, anticardiolipin antibodies, and/or anti-b2 glycoprotein I antibodies
- Major bleeding event within the previous 3 months prior to the Len-Dex therapy;
- previous recent anticoagulation or on antiplatelet therapy
- previous lenalidomide maintenance therapy
- known allergies to any of the study drugs
- history of gastric or duodenal ulcer
Information from the National Library of Medicine
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
Contacts
| Contact: Martha Louzada, MD MSc (Epid) | 519-685-8500 ext 52391 | Martha.Louzada@lhsc.on.ca | |
| Contact: Kate Kelly, M.Sc. MPH/Gero | 519-685-8500 ext 54511 | Kate.Kelly@lhsc.on.ca |
Locations
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Kate Kelly, MSc, MPH/Gero 5196858500 ext 54511 Kate.Kelly@lhsc.on.ca | |
Sponsors and Collaborators
Lawson Health Research Institute
The Ottawa Hospital
Dalhousie University
St. Boniface Hospital
Hamilton Health Sciences Corporation
Investigators
| Principal Investigator: | Martha Louzada, MD | Lawson Health Research Institute |
Publications of Results:
Other Publications:
Other Publications:
Kamat AV Rivaroxaban Is an Effective and Well Tolerated Anti Thrombotic Agent in Patients on Lenalidomide Therapy and in Multiple Myeloma Blood 2014 124:5095;
| Responsible Party: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT03428373 |
| Other Study ID Numbers: |
10014356 |
| First Posted: | February 9, 2018 Key Record Dates |
| Last Update Posted: | March 10, 2020 |
| Last Verified: | September 2019 |
| 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 |
Keywords provided by Lawson Health Research Institute:
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Multiple Myeloma |
Additional relevant MeSH terms:
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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 Aspirin |
Rivaroxaban Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |