Non-invasive MRD Assessment in Multiple Myeloma

NCT ID: NCT05625971

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2025-12-15

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.

Conditions

Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Myeloma Group

Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging.

MRD Assessment

Intervention Type: OTHER

MRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI).

Interventions

MRD Assessment

MRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hope Foundation

OTHER

Sponsor Role: collaborator

Rajshekhar Chakraborty, MD

OTHER

Sponsor Role: lead

Responsible Party

Rajshekhar Chakraborty, MD

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chakraborty Chakraborty, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAU0686

Identifier Type: -

Identifier Source: org_study_id