Multiple Myeloma Clinical Trial

Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy

Summary

This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.

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Full Description

PRIMARY OBJECTIVE I. To determine the efficacy of xisomab as measured by the incidence of catheter-associated thrombosis (CAT) in individuals with a central venous catheter.

SECONDARY OBJECTIVE:

I. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter.

EXPLORATORY OBJECTIVE:

I. Assessment of drug exposure and catheter occlusions leading to medical intervention.

OUTLINE:

Patients receive xisomab 3G3 intravenously (IV) or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.

After completion of study, patients are followed up for 60 days.

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Eligibility Criteria

Inclusion Criteria:

Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
In consultation with principal investigator (PI) and treating physician, participant's cancer-directed therapy allows for a 1-day period between administration of study drug and subsequent start of planned cancer-directed therapy
Individuals with a confirmed solid malignancy that are scheduled to undergo insertion of a PICC line or indwelling central venous catheter as part of planned anticancer therapy per institutional standards
Must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Platelet count > 100 x 10^9/L
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal
Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria:

Actively receiving treatment in another therapeutic clinical trial
Active acute leukemia (lymphoma and myeloma are allowed)

At time of enrollment, known contraindication to anticoagulation therapy, including:

Clinically significant active bleeding
Individual is within 72 hours of major surgery
Abnormal baseline coagulation tests, including international normalized ratio (INR) > 1.5, or activated partial thromboplastin time (aPTT) prolonged
Abnormal renal function defined by an estimated glomerular filtration rate (eGFR) < 45 mL/min
Abnormal hepatic function defined as liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT] or total bilirubin) > 2 x the upper limit of normal or known Child-Pugh class B or C cirrhosis
Prior history of intracranial hemorrhage
Primary brain tumors or known brain metastasis
Major extracranial bleed within the last 6 months where the cause has not been identified or treated
Known bleeding diathesis
Use of therapeutic anticoagulation or anti-platelet agents for any indication at enrollment
At the discretion of the investigator, any other contraindication to anticoagulation therapy
Presence of a pediatric-sized PICC line
Participant is expected to receive chemotherapy associated with a 15% or higher incidence of grade 3-4 thrombocytopenia within 14 days of receiving study drug
Preexisting intravenous catheter, or indwelling spinal or epidural catheter, at time of enrollment that is intended to remain for the duration of study. Participants may remain eligible if existing catheter is to be removed before placement of a catheter for cancer directed therapy. Removal of existing catheter should occur at least 24 hours prior to PICC or indwelling catheter insertion
Previously documented hypersensitivity to either the drug or excipients
Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment
Participant is allergic to heparin or heparin derivatives
Participants with a history of venous thromboembolism within the last 3 months

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

9

Study ID:

NCT04465760

Recruitment Status:

Terminated

Sponsor:

OHSU Knight Cancer Institute

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There is 1 Location for this study

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OHSU Knight Cancer Institute
Portland Oregon, 97239, United States

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Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

9

Study ID:

NCT04465760

Recruitment Status:

Terminated

Sponsor:


OHSU Knight Cancer Institute

How clear is this clinincal trial information?

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