Randomized Phase 3 study of pomalidomide cyclophosphamide dexamethasone versus pomalidomide dexamethasone in relapse or refractory myeloma: an Asian Myeloma Network study (AMN003)
Bibliographic record
Abstract
Pomalidomide has been shown to improve survival in patients with relapsed/refractory myeloma (RRMM). However, the optimal pomalidomide-based combinations in RRMM are not known. This study compared pomalidomide, cyclophosphamide, dexamethasone (PCD) with pomalidomide and dexamethasone (PD) in Asian patients with RRMM. Patients were randomly assigned to receive PCD or PD. Patients received pomalidomide at 4 mg from days 1 to 21, dexamethasone at 40 mg once a week, and those in the PCD arm received cyclophosphamide at 400 mg once weekly for three weeks. The primary endpoint was progression-free survival. One hundred and twenty-two patients were randomized (62 PCD, 60 PD). Baseline characteristics were comparable between both arms. The median prior lines of therapy were three. At a median follow-up of 13.5 (median range 9-18) months, median progression free survival was significantly longer at 10.9 months (95% confidence interval 7.1-27.7) in the PCD group compared with 5.8 months (95% CI, 4.4-6.9) in the PD group (hazard ratio 0.43; p < 0.001). Adverse events rates were similar in both arms. The most common grade ≥3 adverse events were hematological toxicities and pneumonia. 34 deaths occurred during the study (PCD: 17; PD: 17) and three were deemed to be related to study treatment. In Asian patients with RRMM after exposure to proteasome inhibitor and lenalidomide, progression-free survival was significantly prolonged with the addition of cyclophosphamide to PD, with a manageable safety profile.Trial ID: Registered at www.clinicaltrials.gov : NCT03143049.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".