Table 2.
Clinical outcomes by SCT status in patients with NDMM, overall and by region
| Overall (N = 1511) | Argentina (n = 59) | East Asia (n = 565) | Russia (n = 387) | Saudi Arabia (n = 48) | South Africa (n = 104) | Türkiye (n = 348) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SCT (n = 479) | Non-SCT (n = 987) | SCT (n = 34) | Non-SCT (n = 24) | SCT (n = 167) | Non-SCT (n = 392) | SCT (n = 35) | Non-SCT (n = 352) | SCT (n = 32) | Non-SCT (n = 14) | SCT (n = 41) | Non-SCT (n = 61) | SCT (n = 170) | Non-SCT (n = 144) | |
| Best clinical response to first-line treatment, n (%) | ||||||||||||||
| sCR | 15 (3.1) | 10 (1.0) | 1 (2.9) | 0 | 7 (4.2) | 5 (1.3) | 1 (2.9) | 4 (1.1) | 5 (15.6) | 1 (7.1) | 0 | 0 | 1 (0.6) | 0 |
| CR | 146 (30.5) | 195 (19.8) | 4 (11.8) | 3 (12.5) | 48 (28.7) | 66 (16.8) | 18 (51.4) | 78 (22.2) | 23 (71.9) | 2 (14.3) | 2 (4.9) | 10 (16.4) | 51 (30.0) | 36 (25.0) |
| VGPR | 109 (22.8) | 193 (19.6) | 18 (52.9) | 7 (29.2) | 44 (26.3) | 78 (19.9) | 3 (8.6) | 92 (26.1) | 2 (6.3) | 2 (14.3) | 14 (34.1) | 8 (13.1) | 28 (16.5) | 6 (4.2) |
| PR | 138 (28.8) | 245 (24.8) | 8 (23.5) | 8 (33.3) | 55 (32.9) | 113 (28.8) | 7 (20.0) | 77 (21.9) | 2 (6.3) | 2 (14.3) | 22 (53.7) | 13 (21.3) | 44 (25.9) | 32 (22.2) |
| MR | 4 (0.8) | 27 (2.7) | 0 | 0 | 2 (1.2) | 16 (4.1) | 0 | 4 (1.1) | 0 | 0 | 0 | 1 (1.6) | 2 (1.2) | 6 (4.2) |
| SD | 22 (4.6) | 136 (13.8) | 2 (5.9) | 3 (12.5) | 8 (4.8) | 55 (14.0) | 1 (2.9) | 62 (17.6) | 0 | 1 (7.1) | 2 (4.9) | 3 (4.9) | 9 (5.3) | 12 (8.3) |
| PD | 3 (0.6) | 67 (6.8) | 0 | 2 (8.3) | 0 | 24 (6.1) | 0 | 17 (4.8) | 0 | 6 (42.9) | 1 (2.4) | 16 (26.2) | 2 (1.2) | 2 (1.4) |
| Best clinical response to second-line treatment, n (%) | ||||||||||||||
| sCR | 5 (2.5) | 0 | 2 (14.3) | 0 | 2 (2.2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.1) | 0 |
| CR | 52 (25.9) | 87 (20.2) | 2 (14.3) | 1 (7.1) | 23 (25.6) | 14 (8.5) | 4 (36.4) | 53 (33.1) | 5 (38.5) | 2 (50.0) | 5 (20.0) | 2 (5.7) | 13 (27.1) | 15 (28.8) |
| VGPR | 40 (19.9) | 103 (24.0) | 7 (50.0) | 3 (21.4) | 17 (18.9) | 31 (18.8) | 5 (45.5) | 66 (41.3) | 0 | 1 (25.0) | 5 (20.0) | 0 | 6 (12.5) | 2 (3.8) |
| PR | 42 (20.9) | 78 (18.1) | 0 | 2 (14.3) | 24 (26.7) | 35 (21.2) | 1 (9.1) | 24 (15.0) | 4 (30.8) | 0 | 9 (36.0) | 13 (37.1) | 4 (8.3) | 4 (7.7) |
| MR | 9 (4.5) | 12 (2.8) | 0 | 1 (7.1) | 7 (7.8) | 5 (3.0) | 0 | 3 (1.9) | 1 (7.7) | 0 | 0 | 1 (2.9) | 1 (2.1) | 2 (3.8) |
| SD | 12 (6.0) | 36 (8.4) | 1 (7.1) | 3 (21.4) | 6 (6.7) | 24 (14.5) | 0 | 6 (3.8) | 0 | 0 | 5 (20.0) | 3 (8.6) | 0 | 0 |
| PD | 12 (6.0) | 41 (9.5) | 1 (7.1) | 1 (7.1) | 6 (6.7) | 21 (12.7) | 1 (9.1) | 3 (1.9) | 2 (15.4) | 1 (25.0) | 0 | 15 (42.9) | 2 (4.2) | 0 |
| Best clinical response to third-line treatment, n (%) | ||||||||||||||
| sCR | 3 (3.8) | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (11.1) | 0 | 0 | 0 |
| CR | 13 (16.3) | 47 (32.4) | 1 (9.1) | 1 (20.0) | 5 (13.2) | 4 (6.7) | 1 (50.0) | 36 (78.3) | 0 | 0 | 4 (22.2) | 0 | 2 (20.0) | 6 (28.6) |
| VGPR | 11 (13.8) | 15 (10.3) | 4 (36.4) | 0 | 5 (13.2) | 7 (11.7) | 0 | 6 (13.0) | 0 | 0 | 2 (11.1) | 1 (9.1) | 0 | 1 (4.8) |
| PR | 20 (25.0) | 22 (15.2) | 1 (9.1) | 2 (40.0) | 13 (34.2) | 17 (28.3) | 0 | 1 ( 2.2) | 1 (100) | 0 | 5 (27.8) | 2 (18.2) | 0 | 0 |
| MR | 5 (6.3) | 2 (1.4) | 0 | 0 | 5 (13.2) | 2 (3.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SD | 6 (7.5) | 16 (11.0) | 1 (9.1) | 1 (20.0) | 3 (7.9) | 8 (13.3) | 0 | 2 (4.3) | 0 | 0 | 2 (11.1) | 5 (45.5) | 0 | 0 |
| PD | 9 (11.3) | 18 (12.4) | 2 (18.2) | 1 (20.0) | 5 (13.2) | 10 (16.7) | 1 (50.0) | 1 (2.2) | 0 | 2 (100) | 1 (5.6) | 3 (27.3) | 0 | 1 (4.8) |
| Patients with any documented clinical response from first-line treatment, n (%) | 423 (88.3) | 727 (73.7) | 34 (100) | 19 (79.2) | 159 (95.2) | 293 (74.7) | 30 (85.7) | 288 (81.8) | 32 (100) | 8 (57.1) | 39 (95.1) | 35 (57.4) | 129 (75.9) | 84 (58.3) |
| Median time difference between first response and first relapse/disease progression (IQR), months | 24.7 (10.2–46.3) | 10.8 (1.3–26.9) | 47.7 (9.9–65.8) | 1.0 (0.3–20.9) | 22.3 (10.5–42.3) | 5.7 (1.0–19.0) | 7.9 (3.6–15.1) | 23.6 (9.1–33.0) | 39.0 (28.7–76.9) | 26.8 (-8.5–59.2) | 30.1 (16.6–48.5) | 10.2 (1.0–25.3) | 19.6 (9.1–41.1) | 2.8 (1.3–18.5) |
| Any documented relapse or disease progression after first-line treatment, n (%) | 207 (43.2) | 434 (44.0) | 14 (41.2) | 10 (41.7) | 89 (53.3) | 184 (46.9) | 12 (34.3) | 138 (39.2) | 15 (46.9) | 9 (64.3) | 28 (68.3) | 42 (68.9) | 49 (28.8) | 51 (35.4) |
| Relapse-free rate post first-line treatment, % (95% CI) | ||||||||||||||
| 1-year | 94.2 (91.7–96.0) | 88.4 (86.1–90.3) | 93.9 (77.9–98.4) | 87.1 (65.2–95.7) | 92.6 (87.3–95.7) | 84.3 (79.8–87.8) | 85.7 (69.0–93.8) | 96.2 (93.6–97.8) | 100 (100–100) | 92.3 (56.6–98.9) | 92.6 (78.7–97.5) | 83.3 (71.1–90.6) | 97.0 (92.9–98.7) | 80.1 (72.2–86.0) |
| 2-year | 80.5 (76.5–83.8) | 75.5 (72.4–78.3) | 90.7 (73.8–96.9) | 78.0 (54.8–90.2) | 73.8 (66.2–80.0) | 67.3 (61.6–72.5) | 71.2 (53.1–83.4) | 86.2 (82.0–89.5) | 90.5 (73.4–96.8) | 92.3 (56.6–98.9) | 78.6 (61.5–88.7) | 63.7 (49.4–75.0) | 85.4 (78.8–90.0) | 68.8 (59.6–76.4) |
| 5-year | 58.2 (53.2–62.9) | 49.3 (45.4–53.1) | 66.4 (44.6–81.3) | 57.2 (33.4–75.3) | 47.2 (38.8–55.1) | 35.6 (29.1–42.0) | 68.2 (50.0–81.0) | 60.0 (54.0–65.4) | 68.4 (47.8–82.2) | 59.3 (15.7–86.3) | 22.3 (9.30–38.8) | 29.4 (15.5–44.8) | 71.4 (63.1–78.2) | 57.1 (46.5–66.3) |
| Relapse-free rate post first SCT, % (95% CI) | ||||||||||||||
| 1-year | 85.2 (81.6–88.2) | – | 90.3 (72.8–96.8) | - | 79.6 (72.4–85.1) | - | 77.1 (59.5–87.9) | - | 93.6 (76.9–98.4) | - | 88.9 (73.0–95.7) | - | 89.1 (83.1–93.1) | - |
| 2-year | 74.3 (69.9–78.2) | – | 83.1 (63.9–92.6) | - | 66.2 (58.1–73.1) | - | 68.2 (50.0–81.0) | - | 86.9 (68.8–94.9) | - | 68.2 (49.9–81.0) | - | 81.1 (73.8–86.6) | - |
| 5-year | 54.9 (49.8–59.8) | – | 60.4 (38.2–76.7) | - | 45.4 (37.0–53.4) | - | 65.0 (46.6–78.4) | - | 60.2 (39.4–75.9) | - | 21.7 (8.94–38.0) | - | 68.3 (59.5–75.6) | - |
| Median OS (95% CI) | 114.1 (106.2–NR) | 85.9 (79.2–97.1) | 82.6 (54.3–104.8) | 64.1 (49.8–71.5) | NR | 60.0 (54.7–68.1) | NR | NR | NR (91.4–NR) | 51.4 (11.7–NR) | 84.6 (52.0–NR) | 38.0 (27.6–48.5) | NR (97.7– NR) | 115.4 (82.1–NR) |
| OS rate after start of first-line treatment, % (95% CI) | ||||||||||||||
| 1-year | 96.2 (94.0–97.6) | 90.1 (88.1–91.9) | 91.2 (75.1–97.1) | 91.5 (70.0–97.8) | 95.1 (90.5–97.5) | 84.2 (80.0–87.6) | 100 (100–100) | 96.6 (94.1–98.0) | 100 (100–100) | 76.9 (44.2–91.9) | 92.7 (79.0–97.6) | 85.2 (73.6–92.0) | 97.6 (93.8–99.1) | 92.8 (87.1–96.1) |
| 2-year | 89.7 (86.6–92.1) | 83.5 (81.0–85.8) | 85.3 (68.2–93.6) | 87.1 (65.2–95.7) | 89.4 (83.5–93.3) | 75.9 (71.0–80.1) | 97.1 (80.9–99.6) | 93.7 (90.6–95.8) | 100 (100–100) | 61.5 (30.8–81.8) | 85.3 (70.2–93.1) | 70.0 (56.6–79.9) | 90.3 (84.6–93.9) | 84.5 (76.9–89.7) |
| 5-year | 73.5 (69.1–77.4) | 64.6 (61.2–67.9) | 67.1 (48.4–80.2) | 56.6 (34.4–73.8) | 73.7 (65.9–80.0) | 50.5 (44.2–56.4) | 93.9 (77.8–98.4) | 85.2 (80.8–88.6) | 91.7 (53.9–98.8) | 42.2 (14.9–67.7) | 59.4 (41.5–73.4) | 26.2 (15.7–38.0) | 72.9 (65.0–79.3) | 65.0 (55.2–73.1) |
There were 45 patients with NDMM (Argentina: 1, East Asia: 6, Saudi Arabia: 2, South Africa: 2, Türkiye: 34), in whom the status of SCT at MM diagnosis was reported as ‘unknown’ and these are not included in the above table
CI confidence interval, CR complete response, IQR interquartile range, MR minimal response, NDMM newly diagnosed multiple myeloma, NR not reached, OS overall survival, PD progressive disease, PR partial response, sCR stringent complete response, SCT stem cell transplantation, SD stable disease, VGPR very good partial response