Non-invasive MRD Assessment in Multiple Myeloma

NCT05625971 | Completed DMC

• 1 other identifier: AAAU0686
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of non-invasive MRD assessment

  MRD assessment includes liquid biopsy and functional imaging.

  6 months

• Specificity of non-invasive MRD assessment

  MRD assessment includes liquid biopsy and functional imaging.

  6 months

Secondary Outcomes (4)

• Sensitivity of two MRD-testing algorithms

  6 months

• Specificity of two MRD-testing algorithms

  6 months

• Progression Free Survival

  2 years

• Overall Survival

  2 years

Study Arms (1)

Myeloma Group

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

Other: MRD Assessment

Interventions

MRD Assessment 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).

Myeloma Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed or previously treated myeloma who are initiating a new line of therapy will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajshekhar Chakraborty, MD: lead
• Hope Foundation: collaborator

Study Sites (1)

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow aspirate and biopsy

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chakraborty Chakraborty, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: September 14, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)