Ide-cel is a CAR-T therapy in which the patient's own immune cells are changed so that they attack myeloma cells. This study included people whose myeloma had come back after 2 to 4 lines of treatment (including the three main groups of myeloma drugs). Ide-cel kept the disease under control for about 14 months on average, compared with about 4 months with the usual drug treatments, and a complete response was seen in 44% of patients. Because most patients in the other group later received ide-cel, no difference in length of life was seen between the two groups. No new side effects were reported.
Relapsed or refractory multiple myeloma after 2 or more lines of therapy including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Lymphodepletion | |||
| Cyclophosphamide + fludarabine | Cyclophosphamide 300 mg/m² + fludarabine 30 mg/m² | IV | 3 days |
| Single infusion | |||
| Idecabtagene vicleucel | 300 to 510 × 10⁶ CAR-positive T cells | IV | 2 days after completion of lymphodepletion |
Ensure tocilizumab is available.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Leukapheresis; up to 1 cycle of bridging therapy (DPd, DVd, IRd, Kd or EPd) until 14 days before lymphodepletion; then cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² IV daily for 3 days, starting 5 days before infusion; and a single infusion of idecabtagene vicleucel with a target dose range of 150 to 450 × 106 CAR-positive T cells.
One of five regimens at the investigator's choice based on the most recent treatment: daratumumab–pomalidomide–dexamethasone (DPd), daratumumab–bortezomib–dexamethasone (DVd), ixazomib–lenalidomide–dexamethasone (IRd), carfilzomib–dexamethasone (Kd) or elotuzumab–pomalidomide–dexamethasone (EPd). Patients could cross over to ide-cel on disease progression. Regimen doses in the full text.
Source of the regimen details: FDA label for ABECMA (Clinical Studies section, Study 1 = KarMMa-3); ide-cel dose range from the initial KarMMa-3 report (NEJM 2023)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with relapsed and refractory multiple myeloma after 2 to 4 prior regimens including an immunomodulatory drug, a proteasome inhibitor and daratumumab, refractory to the last regimen, with at least a minimal response to one prior regimen and ECOG 0 or 1. Exclusion criteria: creatinine clearance less than 45 mL/min, AST or ALT more than 2.5 times the upper limit of normal, and LVEF less than 45%.
Primary endpoint: progression-free survival.
Other endpoints: overall and complete response rates, overall survival (with crossover-adjusted analyses), patient-reported outcomes and safety.
According to the abstract, no new safety signal was reported. In the FDA label, deaths during the first 9 months after randomisation were more frequent in the ide-cel group (18% versus 11%); 8% occurred before ide-cel infusion (mainly due to disease progression). In the initial report, grade 3 or 4 adverse events occurred in 93% versus 75%, and cytokine release syndrome in 88% (grade 3 or higher 5%) of ide-cel recipients.
The final progression-free survival analysis confirms the durable benefit of ide-cel compared with standard regimens in triple-class-exposed relapsed and refractory myeloma, especially after 2 prior lines. Overall survival did not differ at the interim analysis, which is partly attributed to crossover of 56% of standard-group patients to ide-cel. The authors stress the importance of individualised bridging therapy.
Crossover of standard-group patients to ide-cel confounds the interpretation of overall survival; crossover-adjusted analyses favoured ide-cel but rely on statistical assumptions. Overall survival was at the interim analysis stage. The abstract does not give adverse-event rates, doses or patient numbers.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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