Lenalidomide (L) in Combination with Dexamethasone (D) Significantly Improves Time to Progression (TTP) in Non-Stem Cell Transplant Patients (pts) with Relapsed or Refractory (rel/ref) Multiple Myeloma (MM): Analysis from MM-009 and MM-010 Randomized Phase III Clinical Trials.
Bibliographic record
Abstract
Abstract INTRODUCTION: Although autologous stem cell transplant (ASCT) has demonstrated high overall survival (OS) and progression free survival (PFS) in MM pts, for many pts this may not be an option due to comorbid conditions, advance age, aggressive refractory disease or personal preferences. Two phase III studies demonstrated superiority of the LD combination over D alone in rel/ref MM pts resulting in approval of L by the FDA. To evaluate the utility of LD combination in non-transplant pts we examined all pts who were enrolled on the MM-090 and MM-010 clinical trials and compared the efficacy and safety profile of LD combination among pts with no prior ASCT (NT) vs. those who had a prior ASCT (PT). METHODS: Data set from the 2 phase III trial was queried and pts with or without a previous ASCT identified. Clinical outcome (overall response rate, ORR; time to progression, TTP; overall survival, OS) was compared between the two groups. RESULTS: Of the 704 pts enrolled 353 (210 in the PT and 143 in the NT group) were randomized to receive LD. Patients demographic are summarized in Table 1. The median dose for L in both group was 25mg. Using the Blade criteria the ORR and CR rates in the PT vs. NT group were 63% (CR =13%) and 55% (CR=16%) p=0.12, while the median TTP was 44.1 and 61.4 (p=0.13), respectively. Toxicity: Although a higher incidence grade 3/4 neutropenia in the PT vs. NT group (38.1% vs. 27.3, p<.05) was noted the incidence of grade 3/4 thrombocytopenia were comparable (5.7% vs. 6.3%). The incidence for toxicity associated discontinuation of therapy in each arm was 12.9% and 19.6%. CONCLUSION: Our analysis showed no difference in ORR and CR rates in the 2 groups though there was a trend towards prolong TTP in NT pts. Although there was a slightly higher incidence of grade 3/4 neutropenia, overall there was no impact of prior ASCT on treatment outcome with LD. An interesting observation was that the median time from first pathologic diagnosis was the same for both groups; this observation is encouraging as they offer advantage to pts who may not have a chance to benefit from ASCT and supports the rationale to investigate L based therapies early on in the course of treatment. Characteristics of patients treated with LD combination. Prior Transplant Group (PT) No Prior Transplant (NPT) P value Median age (range) 59.5 (33–77) 69 (38–86) <0.001 Sex (%) M/F 62.4/37.6 55.2/44.8 0.187 Stage III (%) 60 70.6 0.184 B2M 3.1 4.1 <0.05 Time from first pathologic diagnosis in years (range) 3.4 (0.6–15.7) 2.9 (0.4–14.7) 0.098
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 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 | 0.000 | 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 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".