Table 1 Patient baseline characteristics and adverse events after treatment with MDX-1097

From: A preliminary study of the anti-κ myeloma antigen monoclonal antibody KappaMab (MDX-1097) in pretreated patients with κ-restricted multiple myeloma

	Dose of MDX-1097
	0.3 mg/kg (N = 3)	1.0 mg/kg (N = 3)	3.0 mg/kg (N = 3)	10 mg/kg (N = 3)	Overall (N = 12)
Baseline characteristics
Median age, years (min–max)	78 (63–83)	56 (47–67)	63 (52–63)	63 (62–68)	63 (47–83)
Median ECOG PS (min–max)	1 (1–2)	0 (0–1)	0 (0–1)	0 (0–0)	0 (0–2)
Ongoing maintenance therapy, n
Thalidomide/lenalidomide (Pt. #)	2 (02, 03)	3 (04, 05, 06)	2 (08, 09)	1 (10)	8
Dexamethasone/prednisolone (Pt. #)	2 (02, 03)	2 (05, 06)	2 (08, 09)	1 (12)	7
Cyclophosphamide (Pt. #)	0	1 (05)	0	0	1
Median number of lines of prior antineoplastic therapy^a (min–max)	7 (2–8)	6 (5–10)	4 (3–6)	7 (6–11)	6 (2–11)
Patients with prior ASCT, n (%)	0 (0%)	2 (67%)	3 (100%)	3 (100%)	8 (67%)
Number of patients (%) with AEs [number of AEs]
All treatment-emergent AEs
Grade 1–3	2 (66%) [4]	3 (100%) [3]^b	1 (33%) [2]	2 (67%) [9]	8 (67%) [18]
Grade 4/5	0	0	0	0	0
Total	2 (67%) [4]	3 (100%) [3]	1 (33%) [2]	2 (67%) [9]	8 (67%) [18]
Possibly, probably, or definitely related AEs
Grade 1–3	0	0	0	2 (67%) [6]	2 (17%) [6]
Grade 4/5	0	0	0	0	0
Total	0	0	0	2 (67%) [6]	2 (17%) [6]
Possibly, probably, or definitely related AEs by System Organ Class
MedDRA preferred term
Grade 1–3	0	0	0	2 (67%) [6]	2 (17%) [6]
Grade 4/5	0	0	0	0	0
Total	0	0	0	2 (67%) [6]	2 (17%) [6]
Gastrointestinal disorders
Eructation	0	0	0	1 (33%) [1]	1 (8.3%) [1]
Nausea	0	0	0	2 (67%) [2]	2 (17%) [2]
Total	0	0	0	2 (67%) 3]	2 (17%) [3]
Musculoskeletal and connective tissue disorders
Pain in extremity	0	0	0	1 (33%) [1]	1 (8.3%) [1]
Total	0	0	0	1 (33%) [1]	1 (8.3%) [1]
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0	0	0	1(33%) [1]	1 (8.3%) [1]
Total	0	0	0	1 (33%) [1]	1 (8.3%) [1]
Vascular disorders
Flushing	0	0	0	1 (33%) [1]	1 (8.3%) [1]
Total	0	0	0	1 (33%) [1]	1 (8.3%) 1]

AE adverse event, ASCT autologous stem cell transplantation, ECOG PS European Cooperative Oncology Group performance status, MedDRA Medical Dictionary for Regulatory Activities, N number of patients in treatment group, n number of patients, Pt# patient identification number, SD standard deviation
^aASCTs were not included
^bOne patient experienced grade 3 arthralgia

Back to article page

Table 1 Patient baseline characteristics and adverse events after treatment with MDX-1097

Search

Quick links