Non-invasive MRD Assessment in Multiple Myeloma

Recruiting

• Conditions: Myeloma

• Registration Number: NCT05625971
• Lead Sponsor: Rajshekhar Chakraborty, MD

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.

Study Timeline

• Study Start: 2022-09-14
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of non-invasive MRD assessment	6 months	MRD assessment includes liquid biopsy and functional imaging.
Specificity of non-invasive MRD assessment	6 months	MRD assessment includes liquid biopsy and functional imaging.

Secondary Outcome Measures

Name	Time	Method
Specificity of two MRD-testing algorithms	6 months	Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients
Progression Free Survival	2 years	The progression-free survival (PFS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)
Overall Survival	2 years	The overall survival (OS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)
Sensitivity of two MRD-testing algorithms	6 months	Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients

Trial Locations

Locations (1)

New York Presbyterian Hospital/Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States