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Trial Title:
Non-invasive MRD Assessment in Multiple Myeloma
NCT ID:
NCT05625971
Condition:
Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Liquid biopsy
Minimal Residual Disease (MRD)
Functional imaging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
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.
Criteria for eligibility:
Study pop:
Patients with newly diagnosed or previously treated myeloma who are initiating a new line
of therapy will be recruited.
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
Locations:
Facility:
Name:
New York Presbyterian Hospital/Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Nurse Navigator
Phone:
212-342-5162
Email:
cancerclinicaltrials@cumc.columbia.edu
Investigator:
Last name:
Rajshekhar Chakraborty, MD
Email:
Principal Investigator
Start date:
September 14, 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Rajshekhar Chakraborty, MD
Agency class:
Other
Collaborator:
Agency:
Hope Foundation
Agency class:
Other
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625971
