Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials

Figures & data

Table 1. Baseline characteristics.

	With Moderate RI				Without Moderate RI
	MM-002 (n = 37)	MM-003 (n = 93)	MM-010 (n = 225)	Overall (n = 355)	MM-002 (n = 68)	MM-003 (n = 205)	MM-010 (n = 440)	Overall (n = 713)
Median age (range), years	66 (34–84)	69 (41–84)	72 (46–88)	70 (34–88)	62 (46–80)	61 (35–80)	63 (37–85)	63 (35–85)
ECOG, %^a
0	18.9	38.7	37.8	36.1	35.3	35.6	46.8	42.5
1	70.3	37.6	50.7	49.3	55.9	49.8	43.9	46.7
2	10.8	22.6	11.6	14.4	8.8	14.1	9.1	10.5
ISS stage, %
I	0	10.8	19.1	14.9	0	34.6	28.2	27.3
II	0	36.6	25.3	25.6	0	39.5	29.3	29.5
III	0	49.5	35.1	35.2	0	21.0	20.7	18.8
Missing	100	3.2	20.4	24.2	100	4.9	21.8	24.4
Median time since diagnosis  (range), years	5.8 (1.4–18.1)	5.5 (0.6–30.0)	5.0 (0.7–28.2)	5.3 (0.6–30.0)	5.2 (1.1–17.9)	5.3 (0.8–21.9)	5.3 (0.6–21.4)	5.3 (0.6–21.9)

ECOG: Eastern Cooperative Oncology Group; ISS: International Staging System; RI: renal impairment.

^aOne patient with moderate RI in MM-010 trial and 1 patient without moderate RI in the MM-003 trial had missing ECOG performance status; one patient without moderate RI in the MM-010 trial had ECOG performance status 3.

Table 2. Grade 3/4 AEs.

	With moderate RI				Without moderate RI
	MM-002 (n = 37)	MM-003 (n = 93)	MM-010 (n = 221)	Overall (n = 351)	MM-002 (n = 68)	MM-003 (n = 203)	MM-010 (n = 438)	Overall (n = 709)
Most frequent grade 3/4 AEs (> 5%), %
Neutropenia	40.5	48.4	47.1	46.7	39.7	48.8	51.6	49.6
Febrile neutropenia	2.7	5.4	4.1	4.3	2.9	11.3	6.2	7.3
Thrombocytopenia	16.2	20.4	25.3	23.1	19.1	22.7	23.7	23.0
Anemia	24.3	39.8	37.1	36.5	19.1	29.6	30.4	29.1
Infections	43.2	30.1	31.2	32.2	45.6	30.0	34.7	34.4
Pneumonia	24.3	18.3	12.2	15.1	23.5	9.9	12.8	13.0
Grade 3/4 AEs of interest, %
DVT/PE	2.7	1.1	2.7	2.3	2.9	1.5	1.1	1.4
PN	0	1.1	0.9	0.9	0	1.5	0.7	0.8

AE: adverse event; DVT: deep vein thrombosis; PE: pulmonary embolism; PN: peripheral neuropathy; RI: renal impairment.

Table 3. POM dose intensity and dose modifications due to AEs.

	With moderate RI				Without moderate RI
	MM-002 (n = 37)	MM-003 (n = 93)	MM-010 (n = 221)	Overall (n = 351)	MM-002 (n = 68)	MM-003 (n = 203)	MM-010 (n = 438)	Overall (n = 709)
Median average daily  dose (range), mg/day	4.0 (2.1–4.0)	4.0 (2.6–4.0)	4.0 (1.6–4.0)	4.0 (1.6–4.0)	4.0 (1.6–4.2)	4.0 (2.1–4.0)	4.0 (2.2–4.0)	4.0 (1.6–4.2)
Median relative dose  intensity (range)	0.9 (0.5–1.2)	0.9 (0.4–1.3)	0.9 (0.2–1.3)	0.9 (0.2–1.3)	0.9 (0.2–1.2)	0.9 (0.3–1.2)	0.9 (0.2–1.2)	0.9 (0.2–1.2)
Median Tx duration (range), mo	4.2 (0.5–47.8)	3.6 (0.1–21.4)	4.6 (0.1–25.1)	4.0 (0.1–47.8)	5.7 (0.1–47.6)	4.6 (0.1–20.1)	5.5 (0.2–28.3)	5.1 (0.1–47.6)
Discontinuations due to AE, %	5.4	10.8	5.9	7.1	10.3	6.9	5.5	6.3
Reduction due to AE, %	32.4	28.0	22.6	25.1	25.0	26.6	21.7	23.4
Interruption due to AE, %	73.0	66.7	65.2	66.4	63.2	66.0	67.4	66.6

AE: adverse event; RI: renal impairment; Tx: treatment.

Figure 1. Overall response rate (ORR) in patients with baseline renal impairment (RI; creatinine clearance [CrCl] ≥ 30 and <60 mL/min) and without baseline RI (≥ 60 mL/min). CR: complete response; PR: partial response; sCR: stringent complete response; VGPR: very good partial response.

Table 4. Efficacy outcomes in patients with vs. without moderate RI.

	With Moderate RI				Without Moderate RI
	MM-002 (n = 37)	MM-003 (n = 93)	MM-010 (n = 225)	Overall (n = 355)	MM-002 (n = 68)	MM-003 (n = 205)	MM-010 (n = 440)	Overall (n = 713)
Median PFS (95% CI), months	3.8 (2.8, 7.9)	4.0 (2.8, 4.8)	3.7 (2.8, 4.6)	3.8 (2.9, 4.6)	5.4 (3.7, 6.8)	4.2 (3.7, 5.6)	4.8 (4.1, 5.5)	4.6 (4.1, 5.5)
Median TTP (95% CI), months	4.7 (3.1, 9.3)	4.4 (2.9, 6.5)	4.6 (3.7, 5.4)	4.6 (3.8, 4.9)	5.5 (3.7, 7.2)	4.9 (3.9, 6.7)	5.3 (4.6, 6.0)	5.3 (4.6, 5.8)
Median DOR (95% CI), months	8.3 (5.8, 14.1)	6.6 (3.9, 9.7)	6.8 (4.6, 9.5)	6.9 (5.8, 8.8)	7.7 (3.7, 12.5)	7.0 (5.6, 12.4)	7.9 (6.5, 9.2)	7.6 (6.5, 8.8)
Median OS (95% CI), months	13.4 (8.7, 23.8)	10.4 (6.6, 12.4)	9.8 (8.1, 12.0)	10.5 (8.9, 11.5)	16.9 (13.4, 21.7)	14.6 (11.8, 16.6)	12.9 (11.4, 14.7)	14.0 (12.4, 15.2)

DOR: duration of response; OS: overall survival; PFS: progression-free survival; RI: renal impairment; TTP: time to progression.