Back to results

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

Primary Purpose

Venous Thromboembolism

Status

Terminated

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Apixaban 2.5 MG

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Multiple Myeloma, Venous Thromboembolism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Hospital Clinico Universitario
Hospital Universitario Doctor Peset
Hospital Universitario y Politécnico La Fe
Hospital General Universitario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apixaban (single arm)

Arm Description

Outcomes

Primary Outcome Measures

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Venous thromboembolism (VTE)- related death

i.e. death for which VTE can not be excluded as a cause

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Symptomatic deep-vein thrombosis (DVT)

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Pulmonary embolism (PE)

Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate).

Pulmonary embolism (PE)

Asymptomatic proximal DVT as detected by systematic compression ultrasound

Diagnostic assessment of DVT. Presence of any one of the following will be considered diagnostic for the presence of DVT: New or previously undocumented non-compressibility of one or more proximal venous segments (popliteal vein or higher) of the legs on compression ultrasound. Constant intraluminal filing defect(s) in two or more views on contrast venography in one or more venous segments in the legs or pelvis, or involving the inferior vena cava.

Asymptomatic proximal DVT as detected by systematic compression ultrasound

Secondary Outcome Measures

Major bleeding event

Defined as a bleeding event that is acute clinically overt bleeding accompanied by one or more of the following: A decrease in hemoglobin (Hb) of 2 g/dL or more over a 24-hour period. A transfusion of 2 or more units of packed red blood cells. Bleeding that occurs in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, an operated joint and requires re-operation or intervention, intramuscular with compartment syndrome, retroperitoneal. Bleeding that is fatal.

Clinically relevant non-major bleeding event

Defined as a bleeding event that is: Acute clinically overt bleeding. Does not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following criteria: Epistaxis: need to medical attention from a physician or visits an emergency room, requires an intervention, persists for 5 minutes or more. Gastrointestinal bleed: vomit containing frank blood or coffee ground material which tests positive for blood, endoscopically confirmed bleeding, frank blood per rectum or melena stools. Hematuria: overt spontaneous bleeding, bleeding persists for 24 hours or more after instrumentation. Bruising/ecchymosis: any bruise, which is assessed as "unusual". Hematoma: presence of a hematoma is demonstrated radiographically, and a drop-in hemoglobin is present with no external evidence of bleeding. Hemoptysis: expectoration of blood or blood-stained sputum.

Fatal Bleeding Event

Defined as a bleeding event that determines is the primary cause of death or contributes directly to death.

Liver injury event

Potential or suspected cases of liver injury including but not limited to liver test abnormalities (elevation of ALT, AST, GGT, alkaline phosphatase and total bilirrubin), jaundice, hepatitis or cholestasis events.

Serious adverse events

A Serious Adverse Event is any untoward medical occurrence that: Results in death. Is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Is an important medical event (defined as a medical event(s) that may require medical intervention to prevent one of a serious outcome listed above). Overdose. Second primary malignancies.

Symptomatic DVT or PE occurring during the 90 days of follow-up period

Symptomatic DTV or PE as defined aforementioned, assessed 90 days after the last dose of the study drug.

Death occurring during the 90 days of follow-up period

All cause of mortality occurring during the 90 days after the last dose of the study drug.

Full Information

NCT ID

NCT04106700

First Posted

September 20, 2019

Last Updated

February 12, 2021

Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04106700

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment

Study Start Date

April 12, 2019 (Actual)

Primary Completion Date

August 26, 2020 (Actual)

Study Completion Date

October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

Keywords

Multiple Myeloma, Venous Thromboembolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Clinical trial with a single arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apixaban (single arm)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Apixaban 2.5 MG

Intervention Description

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

Primary Outcome Measure Information:

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 5 Day 1(each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Venous thromboembolism (VTE)- related death

Description

i.e. death for which VTE can not be excluded as a cause

Time Frame

14 days after last dose of apixaban

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 5 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Symptomatic deep-vein thrombosis (DVT)

Description

Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness

Time Frame

14 days after last dose of apixaban

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 5 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Pulmonary embolism (PE)

Description

Time Frame

14 days after last dose of apixaban

Title

Asymptomatic proximal DVT as detected by systematic compression ultrasound

Description

Time Frame

Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Title

Asymptomatic proximal DVT as detected by systematic compression ultrasound

Description

Time Frame

Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6)

Secondary Outcome Measure Information:

Title

Major bleeding event

Description

Time Frame

Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6)

Title

Clinically relevant non-major bleeding event

Description

Time Frame

Title

Fatal Bleeding Event

Description

Defined as a bleeding event that determines is the primary cause of death or contributes directly to death.

Time Frame

Title

Liver injury event

Description

Time Frame

Title

Serious adverse events

Description

Time Frame

Title

Symptomatic DVT or PE occurring during the 90 days of follow-up period

Description

Symptomatic DTV or PE as defined aforementioned, assessed 90 days after the last dose of the study drug.

Time Frame

Day +90 follow-up

Title

Death occurring during the 90 days of follow-up period

Description

All cause of mortality occurring during the 90 days after the last dose of the study drug.

Time Frame

Day +90 follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Javier de la Rubia

Organizational Affiliation

Hospital Doctor Peset

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Samuel Romero

Organizational Affiliation

Hospital Universitario y Politecnico La Fe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clinico Universitario

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital Universitario Doctor Peset

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Hospital Universitario y Politécnico La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Hospital General Universitario

City

Valencia

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs