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

NCT ID: NCT04106700

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-12
• Study Completion Date: 2020-10-05

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apixaban (single arm)

Group Type: EXPERIMENTAL

Apixaban 2.5 MG

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent
• Subjects must have documented newly diagnosed symptomatic multiple myeloma requiring front-line treatment.
• Patients should be considered transplant-eligible
• Subjects will receive front-line induction therapy with a triplet regimen consisting of bortezomib, thalidomide and dexamethasone (VTD).
• To enter to the study at the same time of start anti myeloma induction therapy.
• Ages eligible for study: 18 to 70 years.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.

Exclusion Criteria

• Patients with the diagnosis of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or amyloidosis of light chain.
• Patients with smouldering multiple myeloma or monoclonal gammopathy of undeterminated significance.
• Patients considered non-transplant-eligible.
• Grade ≥2 of peripheral neuropathy.
• Prior history of documented any venous thromboembolism and arterial thrombosis event
• Active or high risk of bleeding.
• Need for on-going anticoagulant or antiplatelet treatment.
• Contraindication of anticoagulant prophylaxis
• Uncontrolled hypertension: systolic blood pressure >200 mmHg and/or diastolic blood pressure >100 mmHg.
• HIV, HBV or HCV-positive active.
• Expected survival <6 months.
• Weight <40 Kg.
• Low platelet count (<50 x109/L).
• ALT >3x UNL, bilirubin >2x ULN.
• Creatinine clearance <30 mL/min.
• Women of childbearing potential who are unwilling to use an acceptable method of contraception.
• Women of childbearing potential who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment, prior to investigational product administration.
• Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study.
• Subjects unwilling or unable to comply with study medication instructions or study procedures (e.g. bilateral lower extremity venous ultrasonography).
• Known allergies to ingredients contained in apixaban.
• Use of any contraindicated medications with apixaban (see section 5.4.1).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier de la Rubia

Role: STUDY_DIRECTOR

Hospital Doctor Peset

Samuel Romero

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario y Politecnico La Fe

Locations

Hospital Clinico Universitario

Valencia, , Spain

Hospital Universitario Doctor Peset

Valencia, , Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Hospital General Universitario

Valencia, , Spain

Countries

Spain

Other Identifiers

APIXABAN

Identifier Type: -

Identifier Source: org_study_id