Non-invasive MRD Assessment in Multiple Myeloma (NIRVANA)

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

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.

Study Overview

• Status: Completed
• Conditions: Myeloma
• Intervention / Treatment: Other: MRD Assessment

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myeloma Group; Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of two MRD-testing algorithms	Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients	6 months
Specificity of two MRD-testing algorithms	Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients	6 months
Progression Free Survival	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)	2 years
Overall Survival	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)	2 years

Collaborators and Investigators

• Sponsor: Rajshekhar Chakraborty, MD
• Collaborators: Hope Foundation
• Investigators: Principal Investigator: Chakraborty Chakraborty, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Liquid biopsy; Minimal Residual Disease (MRD); Functional imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm, Residual; Neoplasms, Plasma Cell
• Other Study ID Numbers: AAAU0686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No