Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study

Figures & data

Table 1. Baseline demographic and disease characteristics.

	DARA SC
	3-week tapering cohort (n = 15)	2-week tapering cohort (n = 15)	1-week tapering cohort (n = 12)	Total (N = 42)
Median (range) age, years	66.0 (59–81)	69.0 (52–86)	72.5 (58–84)	69.5 (52–86)
Age category, years, n (%)
18–<65	4 (26.7)	6 (40.0)	2 (16.7)	12 (28.6)
65–<75	9 (60.0)	7 (46.7)	5 (41.7)	21 (50.0)
≥75	2 (13.3)	2 (13.3)	5 (41.7)	9 (21.4)
Median (range) weight, kg	77.0 (56.0–151.3)	81.0 (50.0–100.0)	76.1 (44.0–103.0)	77.8 (44.0–151.3)
ECOG PS score, n (%)
0	5 (33.3)	8 (53.3)	4 (33.3)	17 (40.5)
1	9 (60.0)	7 (46.7)	6 (50.0)	22 (52.4)
2	1 (6.7)	0	2 (16.7)	3 (7.1)
ISS disease stage,^a n (%)
I	9 (60.0)	8 (53.3)	5 (41.7)	22 (52.4)
II	4 (26.7)	2 (13.3)	6 (50.0)	12 (28.6)
III	2 (13.3)	5 (33.3)	1 (8.3)	8 (19.0)
Type of multiple myeloma,^b n (%)
IgG	9 (60.0)	8 (53.3)	7 (58.3)	24 (57.1)
IgA	1 (6.7)	3 (20.0)	3 (25.0)	7 (16.7)
Light chain	5 (33.3)	4 (26.7)	2 (16.7)	11 (26.2)
Median (range) time from diagnosis, years	6.3 (2.3–19.2)	5.6 (0.7–14.3)	5.8 (2.0–17.2)	5.9 (0.7–19.2)
Median (range) prior lines of therapy	2 (2–7)	2 (2–4)	4 (2–6)	3 (2–7)
Prior lines of therapy, n (%)
≤3	11 (73.3)	14 (93.3)	6 (50.0)	31 (73.8)
>3	4 (26.7)	1 (6.7)	6 (50.0)	11 (26.2)
Prior ASCT, n (%)	14 (93.3)	12 (80.0)	3 (25.0)	29 (69.0)
Prior PI, n (%)
Bortezomib	15 (100.0)	15 (100.0)	12 (100.0)	42 (100.0)
Prior IMiD, n (%)
Lenalidomide	15 (100.0)	14 (93.3)	10 (83.3)	39 (92.9)
Refractory to, n (%)
Bortezomib	6 (40.0)	4 (26.7)	6 (50.0)	16 (38.1)
Lenalidomide	7 (46.7)	8 (53.3)	9 (75.0)	24 (57.1)
PI and IMiD	4 (26.7)	7 (46.7)	8 (66.7)	19 (45.2)
Last line of therapy	6 (40.0)	10 (66.7)	9 (75.0)	25 (59.5)
Cytogenetic profile,^c n (%)	n = 12	n = 12	n = 7	n = 31
Standard risk	9 (75.0)	9 (75.0)	5 (71.4)	23 (74.2)
High risk^d	3 (25.0)	3 (25.0)	2 (28.6)	8 (25.8)

DARA SC: subcutaneous daratumumab (1,800 mg) plus rHuPH20 (30,000 U in 15 mL); ECOG PS: Eastern Cooperative Oncology Group performance status; ISS: International Staging System; Ig, immunoglobulin; ASCT: autologous stem cell transplant; PI: proteasome inhibitor; IMiD: immunomodulatory drug; rHuPH20: recombinant human hyaluronidase PH20.

^aISS staging is derived based on the combination of serum β₂-microglobulin and albumin.

^bBy immunofixation.

^cCytogenetic abnormalities are based on fluorescence in situ hybridization or karyotype testing. Percentages were calculated with the number of patients in each treatment cohort as the denominator.

^dHigh cytogenetic risk was defined as the presence of a t(4;14), t(14;16), or del17p abnormality.

Table 2. Most common TEAEs by preferred term.

	DARA SC
	3-week tapering cohort (n = 15)	2-week tapering cohort (n = 15)	1-week tapering cohort (n = 12)	Total (N = 42)
Most common (≥25%) TEAEs (any grade), n (%)
Hematologic
Anemia	1 (6.7)	2 (13.3)	4 (33.3)	7 (16.7)
Nonhematologic
Nausea	8 (53.3)	3 (20.0)	2 (16.7)	13 (31.0)
Upper respiratory tract infection	6 (40.0)	3 (20.0)	1 (8.3)	10 (23.8)
Nasopharyngitis	5 (33.3)	5 (33.3)	1 (8.3)	11 (26.2)
Headache	5 (33.3)	1 (6.7)	1 (8.3)	7 (16.7)
Fatigue	4 (26.7)	4 (26.7)	1 (8.3)	9 (21.4)
Diarrhea	4 (26.7)	3 (20.0)	4 (33.3)	11 (26.2)
Pyrexia	4 (26.7)	2 (13.3)	3 (25.0)	9 (21.4)
Pain in extremity	4 (26.7)	1 (6.7)	3 (25.0)	8 (19.0)
Dizziness	4 (26.7)	1 (6.7)	0	5 (11.9)
Arthralgia	3 (20.0)	4 (26.7)	3 (25.0)	10 (23.8)
Cough	3 (20.0)	4 (26.7)	0	7 (16.7)
Erythema	2 (13.3)	4 (26.7)	0	6 (14.3)
Asthenia	1 (6.7)	2 (13.3)	4 (33.3)	7 (16.7)
Peripheral edema	1 (6.7)	0	4 (33.3)	5 (11.9)
Muscle spasms	1 (6.7)	0	3 (25.0)	4 (9.5)
Most common (≥5%) grade ≥ 3 TEAEs, n (%)
Hematologic
Anemia	1 (6.7)	1 (6.7)	2 (16.7)	4 (9.5)
Lymphopenia	2 (13.3)	0	1 (8.3)	3 (7.1)
Neutropenia	0	3 (20.0)	0	3 (7.1)
Nonhematologic
Bone pain	1 (6.7)	1 (6.7)	1 (8.3)	3 (7.1)

TEAE: treatment-emergent adverse event; DARA SC: subcutaneous daratumumab (1,800 mg) plus rHuPH20 (30,000 U in 15 mL); rHuPH20: recombinant human hyaluronidase PH20.