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G.H. Jackson et al.
was 1.2 (95% CI: 0.8-1.7) in the CRD group and 0.9 (95% CI: 0.6-1.3) in the CTD group.
The incidence of serious adverse events during induc- tion was similar with CRD and CTD (59.0% vs. 57.7%). Infection accounted for nearly half of all serious adverse events reported during induction (45.2% for CRD vs. 46.4% for CTD). Fatal adverse events occurred in six patients in the CRD group and in three patients in the CTD group. Of the nine patients with grade 5 adverse events, one had three concurrent events (renal failure, liver failure, and sepsis), one had two concurrent events (small bowel obstruction and sepsis), and the remaining seven
patients had one event each (pneumonia [n=2]; sepsis [n=2]; collapse/syncope [n=2]; lower respiratory tract infection [n=1]; hepatitis encephalopathy [n=1]).
Interaction of lenalidomide induction and maintenance
Following ASCT, patients were randomized between maintenance lenalidomide and observation, giving us the opportunity to explore the interaction between induction and maintenance agents in this setting. Of the 2,042 trans- plant-eligible patients who entered the first randomiza- tion, 1,024 entered the maintenance phase and were ran- domized to lenalidomide alone (n=451), to lenalidomide
Figure 2. Outcomes according to induction regimen in selected subgroups. (A) Progression-free survival and (B) overall survival; Hazard ratio <1.00 favors CRD. *Likelihood ratio test for heterogeneity of effect among patients with subgroup data available. CI: confidence interval; CRD: cyclophosphamide, lenalidomide, and dexamethasone; CTD: cyclophosphamide, thalidomide, and dexamethasone; het: heterogeneity; HiR: high risk; HR: hazard ratio; ISS: International Staging System; SR: standard risk; UHiR: ultra-high risk.
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haematologica | 2021; 106(7)