TABLE 1.
Patient characteristics at IRd initiation compared with the study population in the Tourmaline‐MM1 trial.
| Characteristics | Study population (n = 106) | Tourmaline‐MM1 (n = 722) |
|---|---|---|
| Sex (n, %) | ||
| Male | 46 (43.4) | 409 (57) |
| Female | 60 (56.6) | 313 (43) |
| Age (n, %) | ||
| Median | 72.5 | 66 |
| ≥75 | 36 (34) | 108 (15) |
| <75 | 70 (66) | 614 (85) |
| ECOG (n, %) | ||
| ≥2 | 9 (8.5) | 42/712 (6) |
| ISS (n, %) | ||
| I | 26 (24.7) | 459 (64) |
| II | 38 (35.5) | 176 (24) |
| III | 42 (39.8) | 87 (12) |
| R‐ISS (n, %) | ||
| I | 18/80 evaluable pts (22.5) | N/A |
| II | 26/80 evaluable pts (32.5) | N/A |
| III | 36/80 evaluable pts (45.0) | N/A |
| R2‐ISS (n, %) | ||
| I | 17/72 evaluable pts (23.6) | N/A |
| II | 13/72 evaluable pts (18.0) | N/A |
| III | 34/72 evaluable pts (47.2) | N/A |
| IV | 8/72 evaluable pts (11.2) | N/A |
| Cytogenetic risk (n, %) | (Data not available in 24%) | |
| Standard risk | 34/75 evaluable pts (45.3) | 415 (57) |
| High risk | 41/75 evaluable pts (54.7) | 137 (19) |
| del17p | 19/75 evaluable pts (25.3) | N/A |
| Creatinine clearance (n, %) | ||
| eGFR >60 mL/min | 81 (68.4) | 542 (73) |
| eGRR <60 mL/min | 25 (31.6) | 169 (23) (eGFR 30 to ≤60 mL/min) |
| Prior lines of treatment (n, %) | ||
| 1 | 42 (39.8) | 411 (61) |
| 2 | 23 (21.7) | 208 (29) |
| ≥3 | 41 (38.5) | 73 (10) (3 prior lines) |
| Prior lenalidomide (n, %) | 61 (57.5) | 88/722 (12) |
| Lenalidomide‐exposed, non‐refractory | 39 (36.8) | 88/722 (12) |
| Lenalidomide‐refractory | 22 (20.7) | 0 |
| Lenalidomide immediately prior to IRd (n, %) | 16 (15.5) | N/A |
| Lenalidomide‐exposed, non‐refractory | 9 (8.7) | N/A |
| Lenalidomide‐refractory | 7 (6.8) | 0 |
| Prior bortezomib (n, %) | 83 (78.3) | 498 (69) |
| Bortezomib‐exposed, non‐refractory | 69 (65.1) | 486 (67) |
| Bortezomib‐refractory | 14 (13.2) | 12 (2) |
| Prior ASCT | 44.5 (42) | 411 (57) |
Note: High cytogenetic risk defined as the presence of [del17p and/or t(4;14) and/or t(14;16) and/or 1 g gain/amp], detected by fluorescence in situ hybridization (FISH).
Abbreviations: ASCT, autologous stem cell transplant; ECOG, Eastern Cooperative Oncology Group; Egfr EGFR, estimated glomerular filtration rate; ISS, International Staging System; n, number; N/A, not available; R‐ISS, Revised International Staging System; R2‐ISS, Second Revision of the International Staging System.