PF598 STEM CELL YIELD AND TRANSPLANTATION IN TRANSPLANT‐ELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING DARATUMUMAB + BORTEZOMIB/THALIDOMIDE/DEXAMETHASONE (D‐VTD): PHASE 3 CASSIOPEIA STUDY
Bibliographic record
Abstract
Background: High‐dose therapy (HDT) followed by autologous stem‐cell transplantation (ASCT) is the standard of care in transplant‐eligible newly diagnosed multiple myeloma (NDMM). In the phase 3 CASSIOPEIA study, daratumumab + standard‐of‐care regimen VTd (D‐VTd) significantly improved stringent complete response (sCR), complete response or better (≥CR), and minimal residual disease (MRD)‐negative rates and reduced the risk of progression or death versus VTd in NDMM patients who were eligible for transplant. Aims: Here, we assessed stem cell yield and transplantation results among patients receiving D‐VTd versus VTd induction prior to HDT and ASCT in Part 1 of the CASSIOPEIA trial. Methods: In Part 1, transplant‐eligible NDMM patients ages 18–65 years were randomized 1:1 to 4 pre‐transplant induction and 2 post‐transplant consolidation cycles of D‐VTd or VTd alone. After induction, patients underwent stem cell mobilization with cyclophosphamide 3 g/m2 (recommended dose) and granulocyte colony‐stimulating factor (G‐CSF). Peripheral blood stem cells were harvested based on response to mobilization. Plerixafor was administered if stem cell collection failed at first attempt and in accordance with institutional practice. Melphalan 200 mg/m2 IV was given as HDT prior to ASCT. Results: A total of 1,085 patients were randomized to D‐VTd (n = 543) or VTd (n = 542). Among patients who completed mobilization (D‐VTd, 506; VTd, 492), more patients in the D‐VTd arm received plerixafor during mobilization than in the VTd arm (21.7% vs 7.9%). Patients underwent a median (range) of 2 (1–6) versus 1 (1–4) days of apheresis for D‐VTd versus VTd. The median number of CD34+ cells collected was lower in patients receiving D‐VTd versus VTd (6.3 × 106/kg vs 8.9 × 106/kg). Nevertheless, a similar percentage of intention‐to‐treat patients receiving D‐VTd versus VTd underwent ASCT (90.1% vs 89.3%). The median number of CD34+ cells transplanted for D‐VTd versus VTd was 3.3 × 106/kg versus 4.3 × 106/kg. Hematopoietic reconstitution rates were high and similar in transplanted patients receiving D‐VTd versus VTd (99.8% vs 99.6%). For D‐VTd versus VTd, a median (range) of 13.0 (6–54) versus 13.0 (4–43) days was required to achieve sustained absolute neutrophil counts >500 cells/mm3, and a median (range) of 14.0 (2–56) versus 12.0 (1–47) days was required to achieve sustained platelets >20,000 cells/mm3 without transfusion. Summary/Conclusion: Stem cell mobilization and collection was feasible with D‐VTd induction. Adding daratumumab to VTd allowed successful transplantation in patients with NDMM who were transplant eligible.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".