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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004592-31-ES

Enrollment

Registered

2018-04-04

Start date

2018-06-22

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism (VTE) prophylaxis MedDRA version: 20.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865

Interventions

Trade Name: Apixaban (BMS-562247) film coated tablets Pharmaceutical Form: Coated tablet INN or Proposed INN: APIXABAN CAS Number: 503612-47-3 Current Sponsor code: BMS-562247 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed written informed consent: • Each subject, or their legally acceptable representative, must sign an informed consent form indicating that he or she understands the purpose and procedures required for the study, and are willing to participate in the study. Consent to participate in the study will be obtained prior to screening. Target population: • 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. Patient features: • Ages eligible for study: 18 to 70 years. • Genders eligible for study: both. • Race eligible for study: any. • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score =2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Target population exceptions: • 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. Medical history and concurrent diseases: • 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 3x UNL, bilirubin >2x ULN. • Creatinine clearance <30 mL/min. Sex and reproductive status: • 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. Other exclusion criteria: • 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the feasibility of apixaban 2.5 mg given twice daily for the prevention of VTE during induction therapy with VTD in a series of patients with newly diagnosed multiple myeloma considered to be transplant-eligible.;Secondary Objective: To analyze the safety and tolerability of apixaban 2.5 mg given twice daily during induction therapy with VTD. For this purpose, either major bleeding or clinically relevant non-major (CRNM) bleeding and any grade III or higher adverse events related to the study drug will be collected during the study period.;Primary end point(s): Efficacy outcomes will include: • VTE-related death (i.e. death for which VTE can not be excluded as a cause). • Symptomatic DVT. • Fatal or non-fatal pulmonary embolism. • Asymptomatic proximal DVT as detected by systematic compression ultrasound.;Timepoint(s) of evaluation of this end point: During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the feasibility of apixaban 2.5 mg given twice daily for the prevention of VTE during induction therapy with VTD in a series of patients with newly diagnosed multiple myeloma considered to be transplant-eligible.;Secondary Objective: To analyze the safety and tolerability of apixaban 2.5 mg given twice daily during induction therapy with VTD. For this purpose, either major bleeding or clinically relevant non-major (CRNM) bleeding and any grade III or higher adverse events related to the study drug will be collected during the study period.;Primary end point(s): Efficacy outcomes will include: • VTE-related death (i.e. death for which VTE can not be excluded as a cause). • Symptomatic DVT. • Fatal or non-fatal pulmonary embolism. • Asymptomatic proximal DVT as detected by systematic compression ultrasound.;Timepoint(s) of evaluation of this end point: During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)

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Secondary

Measure	Time frame
Secondary end point(s): - Additional secondary efficacy outcomes will include: • The composite of total VTE and VTE-related death occurring up to the time of discontinuation of blinded parenteral therapy. • Symptomatic DVT or non-fatal PE occurring during the 60 day follow-up period. • All cause mortality occurring during 30 days of the study. • All cause mortality during the 90 day period of the study. Secondary efficacy outcomes will also be adjudicated by the ICAC. - Demographics and baseline characteristics: Frequency distributions and summary statistics for demographic and baseline variables will be presented for all subjects. Key demographic and baseline variables to be summarized include: geographic region, age, gender, race, height, weight, body mass index, vital signs (systolic blood pressure, diastolic blood pressure, and heart rate), medical history, previous VTE. The summary will be presented for all subjects. - Safety analyses: The incidence of adjudicated major bleeding events during the treatment period will be summarized. Point estimates with 95% confidence intervals will be presented. The incidence of adjudicated clinically relevant non-major bleeding events during the treatment period will also be summarized, as well as the incidence of the adjudicated composite endpoint of major bleeds or clinical relevant non-major bleeds during the treatment period. The incidence of the composite of adjudicated acute MI and acute stroke during the treatment period and follow up period (60 days after the last dose of study medication) will be summarized. The incidence of adverse events and of marked abnormalities in clinical lab tests will be summarized. All adverse events that are serious or that result in discontinuation of study therapy will be described in depth;Timepoint(s) of evaluation of this end point: During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)	—

Measure

Time frame

Secondary end point(s): - Additional secondary efficacy outcomes will include: • The composite of total VTE and VTE-related death occurring up to the time of discontinuation of blinded parenteral therapy. • Symptomatic DVT or non-fatal PE occurring during the 60 day follow-up period. • All cause mortality occurring during 30 days of the study. • All cause mortality during the 90 day period of the study. Secondary efficacy outcomes will also be adjudicated by the ICAC. - Demographics and baseline characteristics: Frequency distributions and summary statistics for demographic and baseline variables will be presented for all subjects. Key demographic and baseline variables to be summarized include: geographic region, age, gender, race, height, weight, body mass index, vital signs (systolic blood pressure, diastolic blood pressure, and heart rate), medical history, previous VTE. The summary will be presented for all subjects. - Safety analyses: The incidence of adjudicated major bleeding events during the treatment period will be summarized. Point estimates with 95% confidence intervals will be presented. The incidence of adjudicated clinically relevant non-major bleeding events during the treatment period will also be summarized, as well as the incidence of the adjudicated composite endpoint of major bleeds or clinical relevant non-major bleeds during the treatment period. The incidence of the composite of adjudicated acute MI and acute stroke during the treatment period and follow up period (60 days after the last dose of study medication) will be summarized. The incidence of adverse events and of marked abnormalities in clinical lab tests will be summarized. All adverse events that are serious or that result in discontinuation of study therapy will be described in depth;Timepoint(s) of evaluation of this end point: During induction therapy with VTD (C1D1, C2D1, C3D1, C4D1, C5 D1, C6 D1, C6 D28 EOT, 14 days after EOT, 28 days after EOT)

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Countries

Spain

Contacts

Public ContactMaria Cortell

Health Research Institute Hospital La Fe

investigacion_clinica@iislafe.es0034961246611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026