Non-invasive MRD Assessment in Multiple Myeloma

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

Sponsors

Lead Sponsor: Rajshekhar Chakraborty, MD

Collaborator: Hope Foundation

Source Columbia University
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.

Overall Status Recruiting
Start Date 2022-09-14
Completion Date 2024-09-01
Primary Completion Date 2024-09-01
Study Type Observational
Primary Outcome
Measure Time Frame
Sensitivity of non-invasive MRD assessment 6 months
Specificity of non-invasive MRD assessment 6 months
Secondary Outcome
Measure Time Frame
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
Enrollment 88
Condition
Intervention

Intervention Type: Other

Intervention Name: MRD Assessment

Description: 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).

Arm Group Label: Myeloma Group

Eligibility

Sampling Method:

Probability Sample

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Chakraborty Chakraborty, MD Principal Investigator Columbia University
Overall Contact

Last Name: Research Nurse Navigator

Phone: 212-342-5162

Email: [email protected]

Location
Facility: Status: Contact: Investigator: New York Presbyterian Hospital/Columbia University Irving Medical Center Research Nurse Navigator 212-342-5162 [email protected] Rajshekhar Chakraborty, MD Principal Investigator
Location Countries

United States

Verification Date

2022-11-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Columbia University

Investigator Full Name: Rajshekhar Chakraborty, MD

Investigator Title: Assistant Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Myeloma Group

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

Acronym NIRVANA
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myeloma

Clinical Trials on MRD Assessment