Clinical trial · Observational
The Risk Stratification in Patients With Multiple Myeloma Based on Fluorescence Flow Cytometry Quantitative Determination of the Circulating Plasma Cells in the Peripheral Blood
NCT04242121CI-TRIAL-00076929terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment
Summary
Brief summary (as posted)
The main aim of this study is to evaluate the effectiveness of the clinical application of the XN-1000/20 hematology analyzer for risk stratification in patients with multiple myeloma based on the number of detected plasma cells in peripheral blood at the different stages of treatment. This clinical study is observational and does not involve drugs. 100 subjects with newly diagnosed multiple myeloma will be enrolled in this study and followed for 3 years.
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 | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence flow cytometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time-to-progression according to circulating plasma cells
- timeFrame
- [Time Frame: 3 years]
- description
- Measured by cumulative incidence estimates
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- [Time Frame: 3 years]
- description
- Measured by Kaplan-Meier estimates
- measure
- Overall survival
- timeFrame
- [Time Frame: 3 years]
- description
- Measured by Kaplan-Meier estimates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis: Newly diagnosed symptomatic multiple myeloma * Signed informed consent * No second tumors Exclusion Criteria: * Monoclonal gammopathies of undefined significance * Smoldering Multiple Myeloma * Plasma cell leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.