Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis
Bibliographic record
Abstract
ABSTRACT: Genetic abnormalities in multiple myeloma (MM) influence treatment outcomes and may inform therapeutic decisions. The most common chromosomal translocation in MM is t(11;14); however, its role in disease progression is not well defined. We report results from MEDICI, a global, minimally invasive, prospective study evaluating t(11;14) status in newly diagnosed MM (NDMM) and relapsed/refractory MM (RRMM). MEDICI enrolled adult patients (≥18 years) with MM with bone marrow (BM) aspirates collected at diagnosis and/or disease relapse. The primary objective was to determine t(11;14) prevalence in patient BM samples using fluorescent in situ hybridization (FISH) with plasma cell enrichment. Samples from 525 patients (NDMM, n = 306; RRMM, n = 219) were analyzed for t(11;14), with 498 patients (95%) having successful BM FISH test. Prevalence of t(11;14) was 22.1% (110/498 patients; 95% confidence interval [CI], 18.5-26.0) in the overall patient population, 18.8% (56/298 patients; 95% CI, 14.5-23.7) in NDMM, and 27.0% (54/200 patients; 95% CI, 21.0-33.7) in RRMM. Patients with t(11;14)-positive MM were evenly distributed across disease stages (stage I, 24.1%; stage II, 20%; stage III, 21.3%); however, higher rates were observed in African American patients (RRMM odds ratio [OR], 7.27, 95% CI, 1.33-39.83; P = .022) and light-chain only disease (NDMM OR, 3.02, 95% CI, 1.33-6.87; P = .008). Chromosome 1q abnormalities occurred more often in the absence of t(11;14); however, higher frequency of mutation in the plasma cell differentiation regulator IRF4 was detected in t(11;14) presence. In conclusion, the results from MEDICI demonstrated reproducible t(11;14) detection with a real-world prevalence of 22.1% in MM. This trial was registered at www.ClinicalTrials.gov as #NCT04721002.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".