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Non-invasive MRD Assessment in Multiple Myeloma

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Conditions

MyelomaLiquid biopsyMinimal Residual Disease (MRD)Functional imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.

Official Title

Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy

Quick Facts

Study Start:2022-09-14
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05625971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age ≥18 years
  2. * Patients with newly diagnosed multiple myeloma
  3. * Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
  4. * Expected life expectancy of greater than one year and intention to start a new line of treatment
  1. * Patients without cognitive capacity to give informed consent for participation
  2. * Patients with contraindications to MRI, which include the following:
  3. * Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
  4. * Pacemaker
  5. * Metallic implants, which would prohibit patient from undergoing MRI All subjects will be screened for any contraindication to MRI as per their guidelines at the time of patient enrollment.
  6. * Patients must not receive granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) injection within 1 week prior to WB-DWI.
  7. * Patients must not have been initiated on treatment prior to baseline disease assessment by bone marrow aspiration/biopsy and/or WB-DWI Up to 160 mg of dexamethasone (or equivalent) and/or 1 dose of bortezomib (+/- Cyclophosphamide-Dexamethasone) is allowed prior to disease assessment by bone marrow aspiration and WB-DWI.

Contacts and Locations

Principal Investigator

Chakraborty Chakraborty, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Rajshekhar Chakraborty, MD

  • Chakraborty Chakraborty, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2022-09-14
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • Liquid biopsy
  • Minimal Residual Disease (MRD)
  • Functional imaging

Additional Relevant MeSH Terms

  • Myeloma