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Recruiting NCT05625971

Non-invasive MRD Assessment in Multiple Myeloma

Conditions: Myeloma

Sex: All
Ages: 18 Years – N/A
Enrollment: 88
Sponsor: Rajshekhar Chakraborty, MD

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Adults age ≥18 yearsPatients with newly diagnosed multiple myelomaPatients with previously treated multiple myeloma with a maximum of two prior lines of therapyExpected life expectancy of greater than one year and intention to start a new line of treatmentExclusion Criteria:Patients without cognitive capacity to give informed consent for participationPatients 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)PacemakerMetallic 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05625971). StuddyBuddy aggregates publicly available trial information.