TABLE 1.
Patient demographics, disease characteristics and upfront treatment, by immunoglobulin use at 24 months.
| Characteristics: median (IQR) or percentage (%) | No Immunoglobulin within 24 months of MM diagnosis (1031 patients)* | Immunoglobulin within 24 months of MM diagnosis (209 patients) | All patients (2374 patients) | p‐Value |
|---|---|---|---|---|
| Age at diagnosis (years) | 65.28 (58.00, 72.60) | 62.62 (55.59, 69.50) | 66.43 (58.41, 73.50) | 0.01 |
| Female gender | 411/1031 (39.9%) | 86/209 (41.1%) | 968/2373 (40.8%) | 0.73 |
| ECOG 2–4 | 102/674 (15.1%) | 20/159 (12.6%) | 301/1638 (18.4%) | 0.41 |
| Abnormal FISH | 399/610 (65.4%) | 96/121 (79.3%) | 1015/1422 (71.4%) | 0.003 |
| ISS‐3 | 230/802 (28.7%) | 45/172 (26.2%) | 581/1857 (31.3%) | 0.51 |
| Serum Immunoglobulin (excluding paraprotein) (g/L) | 23.00 (19.00, 40.00) | 20.35 (16.60, 24.55) | 23.00 (18.20, 32.00) | 0.006 |
| Serum IgA levels (excluding paraprotein) (g/L) | 0.50 (0.28, 1.10) | 0.41 (0.21, 1.10) | 0.50 (0.27, 1.20) | 0.42 |
| Serum IgM levels (excluding paraprotein) (g/L) | 0.20 (0.18, 0.40) | 0.20 (0.13, 0.36) | 0.20 (0.15, 0.40) | 0.11 |
| Serum IgG levels (excluding paraprotein) (g/L) | 6.00 (4.00, 10.30) | 5.20 (3.25, 7.15) | 6.10 (3.90, 10.10) | 0.002 |
| Baseline hypogammaglobulinaemia (Serum IgG < 7 g/L excluding paraprotein) | 345/616 (56.0%) | 101/140 (72.1%) | 842/1485 (56.7%) | <0.001 |
| Baseline severe hypogammaglobulinaemia (Serum IgG < 4 g/L excluding paraprotein) | 152/616 (24.7%) | 49/140 (35.0%) | 374/1485 (25.2%) | 0.013 |
| Comorbidity – Cardiac disease | 97/924 (10.5%) | 15/186 (8.1%) | 248/2121 (11.7%) | 0.31 |
| Comorbidity – Pulmonary disease | 44/924 (4.8%) | 7/186 (3.8%) | 104/2121 (4.9%) | 0.55 |
| Comorbidity – Diabetes | 122/924 (13.2%) | 19/186 (10.2%) | 300/2121 (14.1%) | 0.26 |
| Comorbidity – Liver disease | 11/924 (1.2%) | 2/186 (1.1%) | 35/2121 (1.7%) | 0.89 |
| First‐line ASCT | 550/1031 (53.3%) | 124/182 (68.1%) | 983/1998 (49.2%) | <0.001 |
| First‐line PI‐based therapy (mainly bortezomib) | 883/1016 (86.9%) | 187/206 (90.8%) | 1983/2309 (85.9%) | 0.13 |
| First‐line IMiD‐based therapy (mainly thalidomide) | 196/1016 (19.3%) | 92/206 (44.7%) | 772/2309 (31.3%) | <0.001 |
| First‐line Anti‐CD38 therapy (mainly daratumumab) | 17/1016 (1.7%) | 8/206 (3.9%) | 79/2309 (3.4%) | 0.041 |
| First‐line treatment with regimen containing dexamethasone | 952/1016 (93.7%) | 197/206 (95.6%) | 2150/2309 (93.1%) | 0.29 |
Note: Patients who survived and completed 24 months duration of follow‐up are included in the groups comparing immunoglobulin versus no immunoglobulin administration within 24 months of MM diagnosis. There were 301 patients excluded from the no immunoglobulin group (as they had died and not yet started immunoglobulin before death) to eliminate survival bias. All patients included in subsequent analyses and are reported in column “All patients.”
Abbreviations: ASCT, autologous stem cell transplant; ECOG, European Cooperative Oncology Group; FISH, fluorescent in‐situ hybridisation; IMiDs, immunomodulatory drugs; IQR, interquartile range; ISS, international staging system; MM, multiple myeloma.