Table 2.
Incidence of SPMs with lenalidomide (Len)-based therapy in selected trial cohorts based on retrospective or post hoc analyses.
| Trial/Location | Reference | N | F/u | Patient population | Treatment | Invasive SPMs | Cumulative incidence of SPMsa (%) | IRb | SIRc (95% CI) | Types (number of cases) |
|---|---|---|---|---|---|---|---|---|---|---|
| PMH | [60] | 230 | N/A | RRMMd | Len-based | 6f | 2.6 | Not reported | Not reported | MDS/AML |
| Cornell | [59] | 68 | >5 yrs | NDMMe | BiRDg | 5 | 7.4h | 2.85 | 1.36 | MDS/AML (0), solid (5) |
| MM009-010 | [58] | 704 | 48 mo | RRMM | Len/dex | 8 | 2.3 | 1.71 | N/A | MDS (2), AML (0), solid (6), B-cell (0) |
| Pooled data | [58] | 3839 | N/A | RRMM | Len-based | 57 | 1.5 | 2.35 | 0.77 (0.43–1.28) | MDS (8), AML (1), B-cell (2), solid (46) |
aExcluding nonmelanoma skin cancers.
bIncidence rate per 100 person-years at risk.
cStandardized incidence ratio (i.e., ratio of observed/expected rates).
dRelapsed and/or refractory multiple myeloma.
eNewly diagnosed multiple myeloma.
fOnly MDS/AML was reported.
gClarithromycin, lenalidomide, and dexamethasone.