Table 1. . Differences in baseline characteristics between patient populations.
| Variable, % | Unadjusted comparison | Adjusted comparison (Primary analysis) |
Fully adjusted comparison |
|
|---|---|---|---|---|
| MajesTEC-1 (n = 165) | RWPC cohort NOBS = 766 |
RWPC cohort ESS = 326 |
RWPC cohort ESS = 195 |
|
| Refractory status | ||||
| Penta-refractory† | 30.3 | 27.5 | 32.7 | 31.7 |
| Triple- or quad-refractory‡ | 47.3 | 39.3 | 46.4 | 46.8 |
| Other | 22.4 | 33.2 | 20.9 | 21.5 |
| Time to progression on last LOT, >4 mo | 61.8 | 59.3 | 60.0 | 61.3 |
| Cytogenetic risk | ||||
| High§ | 23.0 | 21.3 | 22.6 | 21.2 |
| Standard | 66.7 | 53.3 | 66.7 | 67.1 |
| Unknown | 10.3 | 25.5 | 10.7 | 11.7 |
| ISS stage | ||||
| Stage I¶ | 53.3 | 38.8 | 52.6 | 52.8 |
| Stage II¶ | 34.5 | 32.0 | 35.7 | 35.1 |
| Stage III¶ | 12.1 | 29.2 | 11.8 | 12.0 |
| Number of prior LOT >4 | 52.7 | 54.7 | 56.0 | 56.1 |
| Time since MM diagnosis, ≥6 years | 50.9 | 27.0 | 52.3 | 51.6 |
| Age ≥65 years | 47.8 | 64.2 | 48.1 | 48.4 |
| Hemoglobin ≥12 g/dl | 24.8 | 32.9 | 24.2 | 25.0 |
| Prior HSCT | 81.8 | 32.4 | 39.5 | 81.1 |
| ECOG performance status 1 | 66.7 | 68.8 | 65.7 | 61.8 |
| Race | ||||
| White | 81.2 | 73.0 | 69.3 | 80.0 |
| Black/African–American | 12.7 | 11.4 | 15.6 | 14.0 |
| Not reported/other | 6.1 | 15.7 | 15.1 | 6.0 |
| Male sex | 58.2 | 50.1 | 53.5 | 56.1 |
| Type of MM | ||||
| IgG | 55.2 | 60.4 | 64.3 | 57.5 |
| Light chain | 21.8 | 15.7 | 15.4 | 20.7 |
| Other | 23.0 | 23.9 | 20.3 | 21.7 |
†
Refractory to ≥2 IMiDs, 2 PIs and an anti-CD38 monoclonal antibody.
‡
Refractory to 2 IMiDs and 1 PI; or 2 PIs and 1 IMiD; or 2 IMiDs and 2 PIs.
§
≥1 del17p, t(14;16) or t(4;14).
¶
ISS stage was imputed for two observations in the MajesTEC-1 cohort.
ECOG: Eastern Cooperative Oncology Group; ESS: Effective sample size; HSCT: Hematopoietic stem cell transplantation; IMiD: Immunomodulatory drug; ISS: International Staging System; LOT: Line of therapy; MM: Multiple myeloma; mo: Months; NOBS: Number of observation; PI: Proteasome inhibitor; RWPC: Real-world physician’s choice.