Clinical Trials Logo

Clinical Trial Summary

The intended study is designed as a a phase IV pragmatic 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. The pilot feasibility study was conducted in preparation for this randomized controlled trial designed to assess the effect of an intervention.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03428373
Study type Interventional
Source Lawson Health Research Institute
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 17, 2019
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01435720 - Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL) Phase 1/Phase 2
Recruiting NCT04094961 - Ixazomib + Pomalidomide + Dexamethasone In MM Phase 1/Phase 2
Recruiting NCT06068400 - Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Multiple Myeloma N/A
Recruiting NCT03601624 - Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans Phase 2
Recruiting NCT05020444 - TriPRIL CAR T Cells in Multiple Myeloma Phase 1
Not yet recruiting NCT03706547 - Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM Phase 1
Active, not recruiting NCT02970747 - Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone or in Combination With Darzalex® and Dexamethasone in Multiple Myeloma Patients
Not yet recruiting NCT06411301 - A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors Phase 1
Completed NCT01965353 - A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma Phase 1
Not yet recruiting NCT05581875 - A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory Phase 1/Phase 2
Terminated NCT03687125 - Tinostamustine Conditioning and Autologous Stem Cell Phase 1/Phase 2
Recruiting NCT06282978 - Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes Phase 2
Recruiting NCT06158412 - All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma Phase 2
Active, not recruiting NCT03030261 - Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma Phase 2
Recruiting NCT04925193 - Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma Phase 2
Recruiting NCT05121103 - A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma Phase 1
Recruiting NCT04603872 - CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies Early Phase 1
Recruiting NCT04657861 - APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma Early Phase 1
Terminated NCT05191472 - Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies Phase 2
Completed NCT03136653 - A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma Phase 1/Phase 2