Assessing minimal residual disease in multiple myeloma using non-invasive methods
Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
This study is testing whether new non-invasive methods, like blood tests and whole body MRI, can help doctors check for leftover cancer in people with multiple myeloma instead of using traditional bone marrow biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | Cyclophosphamide |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05625971 on ClinicalTrials.gov |
What this trial studies
This study investigates the sensitivity and accuracy of non-invasive methods for assessing minimal residual disease (MRD) in patients with newly diagnosed and previously treated multiple myeloma. It utilizes liquid biopsy to detect circulating tumor cells and functional imaging through whole body MRI to identify focal myeloma lesions. The goal is to determine if these non-invasive techniques can replace traditional bone marrow aspiration and biopsy for MRD assessment. By comparing these methods to the gold standard, the study aims to provide reliable alternatives for MRD evaluation in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed multiple myeloma or those with previously treated myeloma having undergone a maximum of two prior lines of therapy.
Not a fit: Patients who cannot undergo MRI due to contraindications or those without the cognitive capacity to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for monitoring minimal residual disease in multiple myeloma patients.
How similar studies have performed: While there is a growing interest in non-invasive MRD assessment, this study aims to provide prospective data, making it a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Chakraborty Chakraborty, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.