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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
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
The Ottawa Hospital
Dalhousie University
St. Boniface General Hospital Research Centre
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Lawson Health Research Institute

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

Detailed Description:
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.

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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 related topics: Multiple Myeloma
Drug Information available for: Rivaroxaban

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




Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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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
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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
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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 General Hospital Research Centre
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Martha Louzada, MD Lawson Health Research Institute

Publications of Results:

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;

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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

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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:
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
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants