ASA vs. Rivaroxaban in Newly Diagnosed or Relapsed and Refractory Multiple Myeloma Patients Treated With Len-Dex Combination Therapy.

Study Purpose

The intended pilot study is designed as a multicenter randomized controlled clinical trial, comparing the impact of two different therapies including ASA vs.#46; Rivaroxaban in newly diagnosed or relapsed and refractory multiple myeloma patients treated with Lenalidomide Dexamethasone (Len-Dex) combination therapy

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03428373
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lawson Health Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martha Louzada, MD
Principal Investigator Affiliation Lawson Health Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOther
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma in Relapse, Multiple Myeloma Progression, Multiple Myeloma Stage II, Multiple Myeloma Stage I, Multiple Myeloma With Failed Remission, Multiple Myeloma Stage III
Additional Details

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.

Arms & Interventions

Arms

Experimental: Len-Dex+Rivaroxaban

Patients with MM will receive Len-Dex combination and Rivaroxaban (10 mg) daily

Active Comparator: Len-Dex+ASA

Patients MM will receive Len-Dex combination and ASA 81 mg daily

Interventions

Drug: - Rivaroxaban

Rivaroxaban 10mg daily

Drug: - ASA

ASA 81mg

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London Health Sciences Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre

London, Ontario, N6A 5W9

Site Contact

Kate Kelly, MSc, MPH/Gero

Kate.Kelly@lhsc.on.ca

5196858500 #54511