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Phase Ib/II Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis [NEXICART-2]

UCI Specialty Area: Cancer
Principal Investigator: Stefan Octavian Ciurea
A Study On:
Multiple Myeloma

Study Description

Open-label Phase 1b Dose Escalation/Dose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).

Eligibility

The study doctor will perform tests and procedures to find out if you can participate in this study.

You will be asked about your personal characteristics such as age, race, weight, height, your

medical history and any medications you may be taking. Your medical records will be accessed

by the study team including your personal medical data. However, the Sponsors team will work

with this data anonymously (without identifying you).

Tests and procedures planned prior to administration of the study drug are:

*Physical examination, including measurements of body height and weight;

*Assessment of personal characteristics such as age, race, etc;

  • Medical history;
  • Evaluation of the medications you have taken in the last 30 days and the medications you

continue to take;

  • Assessment of your physical condition to perform daily activities;

*Echocardiogram (which uses sound waves to create an image of your heart) to check

heart function;

*Electrocardiogram (ECG) to check your heart rhythm;

  • Pulmonary function testing: this includes spirometry, a procedure that uses a device

(spirometer) to measure airflow into and out of your lungs;

*Cardiac monitoring for 7 days, using a wearable patch monitor continuously recording an

ECG;

*Bone marrow tests, performed by aspiration (via a fine needle) or biopsy, to evaluate

your illness;

  • Non-invasive imaging to check your bones for lesions (a PET [positron emission

tomography]-CT [computed tomography] scan, MRI [magnetic resonance imaging], or

skeletal survey, as determined by the study doctor);

  • Vital signs (measurement of blood pressure, heart rate, respiratory rate and body

temperature)

Performance Status (measured using the ECOG PS Scale), and NYHA classification;

  • Blood samples (up to 30 mL; about 6 teaspoons) will be taken for laboratory tests for

assessment of full blood count, clotting, chemistry, and if you are a woman with

childbearing potential, a pregnancy test;

  • 24-hour urine tests (collecting the amount of urine produced in one day), for analysis of

your kidney function;

  • Blood sample for HIV and hepatitis tests (5 mL; about one teaspoon);
  • Serum p-tau217 (a marker for the development of Alzheimers disease) and optional

brain MRI.

Your participation in this study will be confirmed by your study doctor once he/she receives the

results of the relevant tests.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI