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

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: Dalhousie University; Hamilton Health Sciences Corporation; McMaster University; St. Boniface General Hospital Research Centre; St. Boniface Hospital; The Ottawa Hospital
• Treatments: Aspirin; Rivaroxaban

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