Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial

Figures & data

Table 1. Demographic and baseline characteristics of the ITT population and LEN-relapsed or -refractory subgroups.

Characteristic	ITT Population	LEN Relapsed	LEN Refractory
	(N = 112)	(n = 28)	(n = 84)
Age, median (range), years	66.5 (39.0–83.0)	67.5 (39.0–83.0)	66.0 (43.0–82.0)
>65 years, n (%)	62 (55.4)	17 (60.7)	45 (53.6)
Male, n (%)	76 (67.9)	18 (64.3)	58 (69.0)
ECOG PS, n (%)
0	44 (39.3)	14 (50.0)	30 (35.7)
1	67 (59.8)	14 (50.0)	53 (63.1)
2	1 (0.9)	0	1 (1.2)
Renal function, n (%)
≥30 and <45 mL/min	7 (6.3)	3 (10.7)	4 (4.8)
≥45 and <60 mL/min	12 (10.7)	4 (14.3)	8 (9.5)
≥60 mL/min	79 (70.5)	16 (57.1)	63 (75.0)
Missing	14 (12.5)	5 (17.9)	9 (10.7)
Calculated R-ISS stage, n (%)
I	30 (26.8)	5 (17.9)	25 (29.8)
II	53 (47.3)	12 (42.9)	41 (48.8)
III	8 (7.1)	3 (10.7)	5 (6.0)
NE	21 (18.8)	8 (28.6)	13 (15.5)
Calculated IMWG risk, n (%)
Low	9 (8.0)	1 (3.6)	8 (9.5)
Standard	96 (85.7)	25 (89.3)	71 (84.5)
High	7 (6.3)	2 (7.1)	5 (6.0)
Time from MM diagnosis, median (range), years	3.4 (0.5–11.6)	5.0 (1.6–11.2)	3.3 (0.5–11.6)
Number of prior antimyeloma lines, median (range)	1 (1–2)	1 (1–2)	1 (1–2)
1 Prior line of therapy, n (%)	70 (62.5)	21 (75.0)	49 (58.3)
2 Prior lines of therapy, n (%)	42 (37.5)	7 (25.0)	35 (41.7)
Prior therapies, n (%)
LEN	112 (100)	28 (100)	84 (100)
Proteasome inhibitor^a	89 (79.5)	22 (78.6)	67 (79.8)
BORT	87 (77.7)	21 (75.0)	66 (78.6)
CFZ	11 (9.8)	4 (14.3)	7 (8.3)
IXA	4 (3.6)	1 (3.6)	3 (3.6)
Alkylating agents	89 (79.5)	22 (78.6)	67 (79.8)
SCT	78 (69.6)	19 (67.9)	59 (70.2)
Monoclonal antibodies	4 (3.6)	1 (3.6)	3 (3.6)
Elotuzumab	4 (3.6)	1 (3.6)	3 (3.6)
Other agents	8 (7.1)^b	2 (7.1)^c	6 (7.1)^d
Refractory to most recent prior LEN-containing regimen, n (%)^e	84 (75.0)	0	84 (100)
Duration of most recent prior LEN-containing regimen, median (range), months	23.9 (0.4–116.8)	19.8 (0.4–116.8)	24.3 (2.8–99.6)
Most recent prior LEN dose, n (%)
25 mg	35 (31.3)	11 (39.3)	24 (28.6)
20 mg	4 (3.6)	1 (3.6)	3 (3.6)
15 mg	18 (16.1)	2 (7.1)	16 (19.0)
≤10 mg	54 (48.2)	13 (46.4)	41 (48.8)
Missing	1 (0.9)	1 (3.6)	0
Duration of most recent LEN dose, median, months
25 mg	16.6	5.0	24.0
20 mg	43.2	73.9	39.2
15 mg	20.5	1.7	23.1
≤10 mg	25.7	26.5	24.6

BORT: bortezomib; CFZ: carfilzomib; ECOG PS: Eastern Cooperative Oncology Group performance status; IMWG: International Myeloma Working Group; ITT: intention-to-treat; IXA: ixazomib; LEN: lenalidomide; MM: multiple myeloma; NE: not evaluable; R-ISS: revised International Staging System; SCT: stem cell transplant.

^aPatients may have received >1 proteasome inhibitor. ^bIncluding 1 patient who received doxorubicin, 8 patients who received etoposide, and 3 patients who received cisplatin. Patients may have received >1 of these agents. ^cIncluding 2 patients who received etoposide and 1 patient who received cisplatin. Patients may have received >1 of these agents. ^dIncluding 1 patient who received doxorubicin, 6 patients who received etoposide, and 2 patients who received cisplatin. Patients may have received >1 of these agents. ^eRefractoriness to lenalidomide was defined as being refractory to the lenalidomide-containing regimen immediately prior to study entry.

Table 2. Response by mIMWG criteria in the ITT population and LEN-relapsed or -refractory subgroups.

Response, n (%)	ITT Population	LEN Relapsed	LEN Refractory
	(N = 112)	(n = 28)	(n = 84)
CBR	96 (85.7)	25 (89.3)	71 (84.5)
ORR	87 (77.7)	23 (82.1)	64 (76.2)
CR	30 (26.8)	12 (42.9)	18 (21.4)
VGPR	29 (25.9)	7 (25.0)	22 (26.2)
PR	28 (25.0)	4 (14.3)	24 (28.6)
MR	9 (8.0)	2 (7.1)	7 (8.3)
SD	8 (7.1)	1 (3.6)	7 (8.3)
PD	5 (4.5)	1 (3.6)	4 (4.8)
NE	2 (1.8)	1 (3.6)	1 (1.2)
Missing	1 (0.9)	0	1 (1.2)

CBR: clinical benefit rate; CR: complete response; ITT: intention-to-treat; LEN: lenalidomide; mIMWG: modified International Myeloma Working Group; MR: minimal response; NE: not estimable; ORR: overall response rate; PD: progressive disease; PR: partial response; SD: stable disease; VGPR: very good partial response.

Figure 1. Kaplan-Meier estimates of PFS in the ITT population (A), by lenalidomide-relapsed or -refractory status (B), and by prior line of therapy (C). ITT: intention-to-treat; NE: not estimable; PFS: progression-free survival.

Table 3. Select grade 3/4 TEAEs in the safety population.

TEAEs, n (%)^a	Safety population
	(N = 112)
≥1 Grade 3/4 TEAEs	109 (97.3)
Grade 3/4 hematologic TEAEs^b
Neutropenia	72 (64.3)
Febrile neutropenia	11 (9.8)
Anemia	20 (17.9)
Thrombocytopenia	16 (14.3)
Leukopenia	10 (8.9)
Grade 3/4 nonhematologic TEAEs^b
Infections and infestations	41 (36.6)
Pneumonia	18 (16.1)
Influenza	5 (4.5)
Sepsis	5 (4.5)
Parainfluenza virus	5 (4.5)
Pneumocystis jirovecii pneumonia	4 (3.6)
Back pain	7 (6.3)
Fatigue	6 (5.4)
Hypertension	6 (5.4)
Insomnia	6 (5.4)
Chronic obstructive pulmonary disease	6 (5.4)
Hyperglycemia	6 (5.4)
Hypokalemia	6 (5.4)
Atrial fibrillation	5 (4.5)
Cataract	5 (4.5)
Dyspnea	5 (4.5)
Diarrhea	4 (3.6)
Hyponatremia	4 (3.6)
Hypophosphatemia	4 (3.6)
Pulmonary embolism	4 (3.6)
Syncope	4 (3.6)

TEAE: treatment-emergent adverse event.

^aTEAE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

^bReported in ≥3% of the safety population.

Figure 2. Mean change from baseline in EQ-5D at cycle 12. ECOG PS: Eastern Cooperative Oncology Group performance status; IMWG: International Myeloma Working Group; LCL: lower confidence limit; LEN: lenalidomide; R-ISS: revised International Staging System; SCT: stem cell transplant; Tx: treatment; UCL: upper confidence limit.

Figure 3. Resolution and deterioration of EQ-5D domains at cycle 12.

Data availability statement

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