Clinical trial · Interventional
Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MIDAS inclusions terminated before first inclusion in PENTI-MIDAS
Summary
Brief summary (as posted)
The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga-PentixaFor/FDG discordances explored.
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 |
|---|---|---|---|
| [68Ga]Ga-PentixaFor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-PentixaFor
- interventionNames
- Drug: [68Ga]Ga-PentixaFor
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- 6 months
- description
- To determine the sensitivity of \[68Ga\]Ga-PentixaFor-PET to detect Multiple Myeloma lesions \[Bone marrow (BM) lesions and/or extra-medullary disease (EMD)\] at the time of initial diagnosis in high risk MM patients included in the MIDAS study.
Secondary outcomes (8)
- measure
- Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.
- timeFrame
- 1 month
- description
- The specificity (PPV and NPV) of \[68Ga\]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria are identical to inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) . Exclusion Criteria: * Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with: 1. eGFR \< 50 ml/min by MDRD or CKDEPI. 2. Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years. 3. Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
References
Publications (0)
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