The Combination of Cyclophosphamide-Bortezomib-Dexamethasone (CYBOR-D) Is a Highly Effective and Well Tolerated Regimen that Produces Rapid and Complete Hematological Response In Patients with AL Amyloidosis
Bibliographic record
Abstract
Abstract Abstract 3063 Background: The combination of Cyclophosphamide, Bortezomib, and Dexamethasone (CYBOR-D) is proven to be highly active and effective in multiple myeloma. (Reeder, Leukemia 2009) We aim to evaluate the safety and efficacy of this regimen in a separate plasma cell neoplasm, AL Amyloidosis. The primary endpoint of this study is hematologic response. Complete hematologic response is defined as normalization of the free light chain ratio with no evidence of a monoclonal protein by immunofixation. Partial hematologic response is defined as a 50% reduction in M-spike or absolute light chain level (Gertz Am J Heme 2006). Methods: We report a series of patients with symptomatic AL Amyloidosis who received treatment with a combination of Bortezomib (1.3mg/m2 on days 1, 4, 8, and 11 every 28 days or 1.5 mg/m2 weekly), Cyclophosphamide (300 mg/m2 orally weekly) and Dexamethasone (40 mg weekly). We include patients in this study regardless of autologous bone marrow transplant candidacy or previous treatment history. Results: Fifteen patients with AL amyloidosis received two to six cycles of CYBOR-D. The treatment history, bone marrow transplant candidacy prior to treatment, hematological response, and status of transplant after therapy are shown in table 1. Of note, 8 (53%) had symptomatic cardiac involvement all of whom had elevated levels of both cardiac biomarkers (Troponin T and B-natriuretic peptide). Complete hematological response occurred in 11 patients (73.3%) with partial hematological response in 3 patients (20.0%). One patient (6.6%) did not achieve a partial response but did receive autologous bone marrow transplant after treatment with CYBOR-D. Median time to response was 2 months. Six patients (40%) had objective evidence of kidney response to therapy with a greater than 50% decrease in proteinuria. Conclusions: CYBOR-D produces a rapid and complete hematological response in the majority of patients with AL amyloidosis regardless of previous treatment history or bone marrow transplant candidacy. Overall, it is well tolerated with few side effects that included peripheral neuropathy and infectious complications. Two patients originally determined to be not eligible for transplant improved sufficiently on CYBOR-D to become eligible and then went on to receive autologous bone marrow transplant. The retrospective nature and small sample size limit this study, and prospective, randomized studies are needed to further elucidate the role of this regimen in AL amyloidosis. Disclosures: Stewart: Millennium Pharmaceuticals, Inc.: Honoraria, Research Funding; Celgene: Honoraria. Fonseca:Amgen: Consultancy; Bristol-Myers Squibb: Consultancy; Celgene: Consultancy, Research Funding; Genzyme: Consultancy; Onyx: Research Funding; Otsuka: Consultancy; Medtronic: Consultancy.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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) | 0.001 | 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".