NCT04106700

Prophylaxis With Apixaban in Transplant Eligible Patients With Multiple Myeloma Receiving Induction Therapy With IMiDs

Venous Thromboembolism Prophylaxis With Apixaban in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma Receiving Induction Therapy With an Immunomodulatory-based Regimen

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Interventional, no-randomized, open-label, and single arm multicentre study of apixaban for the prevention of thromboembolic events during induction therapy in transplant-eligible patients with newly diagnosed multiple myeloma who receive bortezomib, thalidomide, and dexamethasone (VTD) during the induction phase of therapy prior to autologous stem cell transplantation (ASCT). The current study is designed to evaluate the efficacy and safety of apixaban during the induction period. Efficacy will be defined as a composite endpoint of acute symptomatic proximal and distal deep venous thrombosis, pulmonary embolism, VTE related deaths, and acute ischemic stroke.

Detailed description

This study is designed to test the efficacy and safety of the oral anti factor Xa apixaban 2.5 mg given twice daily as a prophylaxis of VTE in transplant-eligible patients with multiple myeloma during the induction therapy with VTD. Induction therapy prior to ASCT will consist in no less than 4 and no more than 6 cycles of VTD, depending on treatment response. Duration of each cycle is 4 weeks if there is not any disease or treatment-related complication; therefore, treatment duration will be around 4-6 months. Daily Prophylaxis with apixaban will continue up to a maximum of 14 days after the last dose of thalidomide. In addition, there will be an additional observation period of 14 (± 7) days, starting the day after the last dose of study medication (until 28 days after the end of the last cycle of VTD).

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Apixaban 2.5 MG	Apixaban will be started simultaneously with anti myeloma treatment on day 1 of cycle 1 of VTD, and continues for 4 to 6 months depending on the number of induction cycles administered to the patient

Timeline

• Start date: 2019-04-12
• Primary completion: 2020-08-26
• Completion: 2020-10-05
• First posted: 2019-09-27
• Last updated: 2021-02-15

Locations

4 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study