Tocilizumab prophylaxis for outpatient administration of teclistamab in relapsed/refractory multiple myeloma.
Bibliographic record
Abstract
e19504 Background: Teclistamab is the first BCMA-directed bispecific antibody approved for the treatment of relapsed and refractory multiple myeloma (RRMM). However, despite the deep and durable response rates achieved, concerns remain regarding the acute toxicity profile, particularly the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). To date, a short hospitalization is still recommended for teclistamab initiation and data on the safety of outpatient treatment remains limited. Methods: We prospectively evaluated the safety of outpatient teclistamab initiation in subjects with triple-exposed RRMM. Subjects received the standard step-up dose (SUD) of 0.06 and 0.3 mg/kg and the first full dose (1.5 mg/kg) in the outpatient clinic on days 1, 3, and 5 of cycle 1, respectively, followed by weekly doses. All subjects received tocilizumab (8 mg/kg) on day 1 before first teclistamab dose. Other premedications consisted of dexamethasone (16 mg), acetaminophen (975 mg) and cetirizine (10 mg) for the SUD and first full dose. To receive outpatient SUD, patients were required to stay within 60 minutes of the hospital and have access to a 24-hour caregiver support. During the first 7 days, subjects were contacted by telephone or videoconference 4 times daily. Adverse events (AEs) were graded according to CTCAE v5.0. CRS and ICANS were graded according to ASTCT guidelines. Results: Between July 24, 2023, and January 6, 2025, 20 subjects received at least 3 doses of teclistamab. Cohort characteristics are presented in Table 1. Fourteen subjects (70%) met at least one exclusion criteria for the MAJESTEC-1 trial. With a median follow-up of 2.2 months (range 0.4-16.0), the ORR was 68%. To date, 16 subjects (80%) experienced at least 1 AE, with grade 3 in 70%. CRS occurred in 2 subjects (10%), all grade 1 (Table 1). One subject received 1 dose of tocilizumab, the other 1 dose of dexamethasone, both without requiring hospitalization. No case of ICANS was reported. Cytopenias were common, with grade 4 neutropenia occurring in 10 subjects (50%); G-CSF used in 9 subjects during SUD. Conclusions: Healthcare resource utilization is a major challenge in the evolving field of cellular immunotherapy. Prophylactic use of tocilizumab reduces both CRS incidence and severity with a very low rate of admission. Our results support that outpatient administration with tocilizumab prophylaxis is a safe and feasible option for teclistamab SUD. Baseline demographics. Characteristics Cohort (N=20) Median age in years (range) 72 (31-91) Male sex (%) 8 (40) Caucasians (%) 14 (70) >1 Extramedullary site of disease (%) 10 (50) High-risk cytogenetic profile - number/total number (%) 9/16 (56) International Staging System 3 number/total number (%) 6/17(35) Median time since diagnosis in years (range) 7.0 (1.5-20.9) Median number of previous lines of therapy (range) 4 (2-8)
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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 | 0.001 |
| 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".