Safety
- There were no discontinuations due to AEs related to daratumumab treatment
- Serious treatment-emergent AEs occurred in 32 (30%) patients
- Few required additional supportive care
- Red blood cell transfusion (38%), platelet transfusion (13%), granulocyte colony stimulating factor (GCSF; 8%)
| Treatment- emergent AE ≥ 20% frequency |
Any Grade n (%) |
Grade 3 or 4 n (%) |
|---|---|---|
| Fatigue | 42 (40) | 3 (3) |
| Anemia | 35 (33) | 25 (24) |
| Nausea | 31 (29) | 0 |
| Thrombocytopenia | 27 (25) | 20 (19) |
| Neutropenia | 24 (23) | 13 (12) |
| Back pain | 23 (22) | 3 (3) |
| Cough | 22 (21) | 0 |
- Grade ≥ 3 anemia and thrombocytopenia occurred more frequently in non-responders (32% and 24%, respectively) than responders (3% and 6%, respectively)
- Grade ≥ 3 neutropenia rates were similar in non-responders (12%) and responders (13%)
Infusion-Related Reactions (IRRs)
- IRRs occurred in 45 (42%) patients
- Predominantly grade 1 or 2
- Grade 3 occurred in 5 (5%) patients; no grade 4 IRRs were reported
- 37% patients experienced IRRs during the first infusion
- 6% patients had > 1 IRR
- Most common IRRs include:
- Nasal congestion (12%), Throat irritation (7%), Cough (6%), Dyspnea (6%), Chills (6%), Vomiting (6%)
- No patient discontinued daratumumab due to IRRs
- No immunogenicity was reported
Discontinuation Rates
- Discontinuations predominantly due to disease progression
- 82 (77%) due to progressive disease
- 3 (3%) withdrew consent due to symptoms related to disease progression
- 5 (5%) due to AEs not related to daratumumab therapy
