Clinical trial · Observational
Non-invasive MRD Assessment in Multiple Myeloma
Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRD Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Myeloma Group
- description
- Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging.
- interventionNames
- Other: MRD Assessment
Primary outcomes (2)
- measure
- Sensitivity of non-invasive MRD assessment
- timeFrame
- 6 months
- description
- MRD assessment includes liquid biopsy and functional imaging.
- measure
- Specificity of non-invasive MRD assessment
- timeFrame
- 6 months
- description
- MRD assessment includes liquid biopsy and functional imaging.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available