Table I.
Patients' characteristics.
| Variable | Active MM (n = 159) | SMM (n = 12) |
|---|---|---|
| Age at vaccination, years; (median, range) | 70 (38–94) | 72 (49–79) |
| Age ≥65 | 94 (59%) | 10 (83%) |
| Gender, female : male | 69 (43%): 90 (57%) | 6 (50%): 6 (50%) |
| ISS (n = 111 evaluable) | ||
| I | 61 (55%) | N/A |
| II | 26 (23%) | N/A |
| III | 24 (21%) | N/A |
| FISH cytogenetics | ||
| Standard risk | 109 (74%) | 6 (75%) |
| High risk | 38 (26%) | 2 (25%) |
| Absolute lymphocyte count, k/μl; median (IQR) | 3·13 (2·11–4) | 3·65 (3·26–4·88) |
| Estimated polyclonal Ig (g/l); median (IQR) | 6·54 (3·82–9·46) | 13·04 (6·4–16·83) |
| IVIG therapy at vaccination time | 26 (16%) | N/A |
| Time since MM treatment start, months; median (range) | 32 (0–314) | N/A |
| Actively treated at time of vaccination | 146 (92%) | N/A |
| Treatment regimen at vaccination, containing: | ||
| IMiD | 90 (57%) | N/A |
| PI | 73 (46%) | N/A |
| DARA | 72 (45%) | N/A |
| IMiD + PI | 31 (20%) | N/A |
| Lines of therapy (median, range) | 2 (1–9) | |
| 0 | 2 (1%) | N/A |
| 1 | 34 (20%) | N/A |
| 2 | 67 (42%) | N/A |
| ≥3 | 58 (37%) | N/A |
| No. anti‐myeloma drugs exposed | ||
| 0–2 | 76 (49%) | N/A |
| 3 | 40 (26%) | N/A |
| ≥4 | 40 (26%) | N/A |
| Prior HSCT | 96 (60%) | N/A |
| Time since HSCT, months; median (IQR) | 36 (20–56) | N/A |
| MM treatment response at vaccination (n = 137 evaluable) | ||
| ≥VGPR | 98 (72%) | N/A |
| ≥PR | 118 (86%) | N/A |
DARA, daratumumab; FISH, fluorescence in situ hybridization; HSCT, haematopoietic stem cell transplantation; IMiD, immunomodulatory drug; ISS, international staging system; IVIG, intravenous immunoglobulin; MM, multiple myeloma; No, number; PI, proteasome inhibitor; PR, partial response; VGPR, very good partial response.