Non-invasive MRD Assessment in Multiple Myeloma

Myeloma Clinical Trial

— NIRVANA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625971
• Other study ID #: AAAU0686
• Status: Recruiting
• Start date: September 14, 2022
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Columbia University
• Contact: Research Nurse Navigator
• Phone: 212-342-5162
• Email: cancerclinicaltrials[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

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).

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rajshekhar Chakraborty, MD	Hope Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of non-invasive MRD assessment	MRD assessment includes liquid biopsy and functional imaging.	6 months
Primary	Specificity of non-invasive MRD assessment	MRD assessment includes liquid biopsy and functional imaging.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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