P169 | REAL-WORLD MINIMAL RESIDUAL DISEASE ANALYSIS IN TRANSPLANT-INELIGIBLE MULTIPLE MYELOMA PATIENTS TREATED WITH DARA-VMP VS. DARA-RD IN THE RANDOMIZED PHASE IV REAL MM TRIAL
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Introduction. Daratumumab-bortezomib-melphalan-prednisone (D-VMP) and daratumumab-lenalidomide-dexamethasone (D-Rd) are standard-of-care regimens for newly diagnosed multiple myeloma (NDMM) patients (pts) ineligible for transplant (NTE). No prospective randomized trial compared D-VMP vs D-Rd, and data on the feasibility of minimal residual disease (MRD) assessment in real-life NTE settings are limited. Methods. REAL-MM is a randomized, multicenter, phase IV trial (NCT03829371), comparing D-VMP vs D-Rd in a real-life population of NTE NDMM pts. The study is actively enrolling. NTE NDMM pts (age ≥65 or with comorbidities) are being randomized 1:1 to D-VMP vs D-Rd and enrolled regardless of performance status and comorbidities. Stratification is based on IMWG frailty score and cytogenetic (CG) risk [high risk (HR)=del(17p) and/or t(14;16) and/or t(4;14)]. MRD is assessed by next-generation-flow in pts achieving ≥ very good partial response (VGPR) at +6, +12 months from randomization and yearly thereafter until +60 months. The primary endpoint of the trial is progression-free survival; the current preliminary analysis focuses on clinical response, MRD negativity (MRD-) rates and safety in the first year after randomization. Results At data cut-off (December 12, 2024), 163 pts were randomized (D-VMP n=81; D-Rd n=82). We excluded from the analysis 43 pts with < 1 year of follow-up, focusing on 120 pts (D-VMP n=61; D-Rd n=59) randomized before December 31, 2023. Baseline characteristics were balanced in D-VMP vs D-Rd arms: median age was 75 (IQR 72-78) vs 76 years (IQR 74-79); 34% vs 37% were frail; 25% vs 22% had HR CG. After a median follow-up of 14 months, ORR was 85% vs 78% (p=0.35) and ≥ VGPR rates were 67% and 59% (p=0.45). MRD- rates were 18% and 19% at 6 months (p=1.00), and 34% vs 27% at 12 months (p=0.43). Among HR CG pts, 12 months MRD- rates were 27% vs 38% (p=0.69) and among frail pts 29% vs 14% (p=0.28). No safety concerns emerged. The most frequent grade 3-4 adverse events were thrombocytopenia (13%) and neutropenia (8%) with D-VMP and neutropenia (28%) and infections (8%) with D-Rd. Conclusions. This preliminary descriptive analysis confirms the applicability of MRD assessment in a real-life NTE NDMM population, including 36% of frail patients. High MRD- rates were observed at 12 months in both arms, including HR CG and frail patients, supporting the use of daratumumab-based combinations in this setting. No new safety data emerged.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.012 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.010 | 0.016 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.007 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 it