Clinical trial NCT05625971: Non-invasive MRD Assessment in Multiple Myeloma
Official title: Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloma
Keywords: Liquid biopsy
Minimal Residual Disease (MRD)
Functional imaging
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Hope Foundation
First posted: 2022-11-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity of non-invasive MRD assessment
timeFrame: 6 months
measure: Specificity of non-invasive MRD assessment
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity of two MRD-testing algorithms
timeFrame: 6 months
measure: Specificity of two MRD-testing algorithms
timeFrame: 6 months
measure: Progression Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Chakraborty Chakraborty, MD
role: PRINCIPAL_INVESTIGATOR
References: