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

Rajshekhar Chakraborty, MD1 site in 1 country36 target enrollmentSeptember 14, 2022

ConditionsMyeloma

InterventionsMRD Assessment

Overview

Phase: Not Applicable
Intervention: MRD Assessment
Conditions: Myeloma
Sponsor: Rajshekhar Chakraborty, MD
Enrollment: 36
Locations: 1
Primary Endpoint: Sensitivity of non-invasive MRD assessment
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.

Registry

clinicaltrials.gov

Start Date

September 14, 2022

End Date

December 15, 2025

Last Updated

3 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rajshekhar Chakraborty, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Rajshekhar Chakraborty, MD

Assistant Professor of Medicine

Columbia University

Eligibility Criteria

Inclusion Criteria

•Adults age ≥18 years
•Patients with newly diagnosed multiple myeloma
•Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
•Expected life expectancy of greater than one year and intention to start a new line of treatment

Exclusion Criteria

•Patients without cognitive capacity to give informed consent for participation
•Patients with contraindications to MRI, which include the following:
•Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
•Pacemaker
•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.
•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.
•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.