Clinical trial · Interventional
"WB-DCE-MRI" in Multiple Myeloma as an Independent Prognostic Factor for Disease-free Survival
Assessment of Dynamic Contrast Enhanced Whole Body MRI (DCE-WB-MRI) as Independent Prognostic Factor for Disease-free Survival in Multiple Myeloma (After Intensification Therapy and Autologous Stem Cell Transplantation Suppressed by Amendment n°3)
- 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 main objective of this study is to examine if absence of a satisfactory response on DCE-WB-MRI (see MR criteria of responders section) after completion of HDT followed by autologous stem-cell transplantation (ASCT) is an independent prognostic factor for EFS in patients with MM, compared with established ones including beta2-microglobulin and cytogenetic abnormalities. Secondary objectives are to examine if the microcirculation parameters obtained from baseline DCE-WB-MRI have prognostic significance and to examine if early DCE-WB-MRI performed after the induction HDT and before ASCT might also provide independent prognostic information for patient outcome, which might help in patient stratification and be integrated into the response criteria in the future.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI WHOLE BODY
- interventionNames
- Device: Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI)
Primary outcomes (1)
- measure
- Maximal percentage of bone marrow measurement on last WB DCE MRI
- timeFrame
- Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year
- description
- Bone marrow enhancement : Enhancement (%) = (SIpost - SIpre) x 100/SIpre, where SIpre is the signal intensity before injection and SIpost is the signal intensity after injection
Secondary outcomes (1)
- measure
- Maximal percentage of bone marrow measurement on initial WB DCE MRI
- timeFrame
- Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient referred to one of the hematology departement associated with the research project, with confirmed multiple myeloma defined according to uniform international criteria. * Whatever stage classification according to Salmon and Durie with a life expectancy of more than 3 months. * Age under 70 years old (amendment n°5) and eligible for autologous stem cell transplantation. * Free and informed consent. Exclusion Criteria: * Patient unfit physically, mentally or legally to give informed consent. * Patient non affiliate with social security scheme * Patient with myeloma without measurable monoclonal immunoglobulin, including measurement of serum free light chains. * Patient with another malignancy excluding basal cell cancer. * Patient who could not undergo MRI (incompatible metallic foreign body, pacemaker, allergy to contrast, claustrophobia despite premedication, pregnancy, renal failure with creatinine clearance \<30 ml/min
References
Publications (0)
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