Page 388: the affiliation for the third author, Maria-Victoria Mateos, should be “University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.”
Page 390: under “Statistical analyses,” in the sentence reading “Data are presented for both the 24- and 18-month cutoffs defining early vs late relapse, respectively,” the word “respectively” should be deleted.
Page 392: in Table 2, under “Late relapse (≥24 mos),” in the row “ORR,” the footnote symbol for the P value should be †, not ‡. The corrected Table 2 is shown below:
. | Early relapse (<24 mos) . | Late relapse (≥24 mos) . | ||||
---|---|---|---|---|---|---|
DARA . | Control . | P . | DARA . | Control . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 121 | 110 | 145 | 141 | ||
ORR | 110 (90.9) | 81 (73.6) | .0004† | 136 (93.8) | 114 (80.9) | .0010† |
≥CR | 56 (46.3) | 15 (13.6) | <.0001† | 83 (57.2) | 42 (29.8) | <.0001† |
sCR | 20 (16.5) | 2 (1.8) | 44 (30.3) | 21 (14.9) | ||
CR | 36 (29.8) | 13 (11.8) | 39 (26.9) | 21 (14.9) | ||
≥VGPR | 94 (77.7) | 43 (39.1) | <.0001† | 114 (78.6) | 83 (58.9) | .0003† |
VGPR | 38 (31.4) | 28 (25.5) | 31 (21.4) | 41 (29.1) | ||
PR | 16 (13.2) | 38 (34.5) | 22 (15.2) | 31 (22.0) | ||
MR | 3 (2.5) | 10 (9.1) | 2 (1.4) | 7 (5.0) | ||
SD | 4 (3.3) | 15 (13.6) | 6 (4.1) | 18 (12.8) | ||
PD | 4 (3.3) | 3 (2.7) | 0 | 2 (1.4) | ||
NE | 0 | 1 (0.9) | 1 (0.7) | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 125 | 115 | 146 | 144 | ||
MRD-negative, n (%) | 28 (22.4) | 3 (2.6) | <.0001§ | 46 (31.5) | 15 (10.4) | <.0001§ |
. | Early relapse (<24 mos) . | Late relapse (≥24 mos) . | ||||
---|---|---|---|---|---|---|
DARA . | Control . | P . | DARA . | Control . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 121 | 110 | 145 | 141 | ||
ORR | 110 (90.9) | 81 (73.6) | .0004† | 136 (93.8) | 114 (80.9) | .0010† |
≥CR | 56 (46.3) | 15 (13.6) | <.0001† | 83 (57.2) | 42 (29.8) | <.0001† |
sCR | 20 (16.5) | 2 (1.8) | 44 (30.3) | 21 (14.9) | ||
CR | 36 (29.8) | 13 (11.8) | 39 (26.9) | 21 (14.9) | ||
≥VGPR | 94 (77.7) | 43 (39.1) | <.0001† | 114 (78.6) | 83 (58.9) | .0003† |
VGPR | 38 (31.4) | 28 (25.5) | 31 (21.4) | 41 (29.1) | ||
PR | 16 (13.2) | 38 (34.5) | 22 (15.2) | 31 (22.0) | ||
MR | 3 (2.5) | 10 (9.1) | 2 (1.4) | 7 (5.0) | ||
SD | 4 (3.3) | 15 (13.6) | 6 (4.1) | 18 (12.8) | ||
PD | 4 (3.3) | 3 (2.7) | 0 | 2 (1.4) | ||
NE | 0 | 1 (0.9) | 1 (0.7) | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 125 | 115 | 146 | 144 | ||
MRD-negative, n (%) | 28 (22.4) | 3 (2.6) | <.0001§ | 46 (31.5) | 15 (10.4) | <.0001§ |
Data shown of the pooled CASTOR and POLLUX data set.
The early-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed <24 months after initiating their first line of therapy; the late-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed ≥24 months after initiating their first line of therapy.
DARA, daratumumab; ITT, intent-to-treat; MR, minimal response; NE, not evaluable; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease.
Response-evaluable population with 1 prior line of therapy. The response-evaluable population was defined as patients with a confirmed diagnosis of MM and measurable disease at the baseline or screening visit who received ≥1 administration of study treatment and had ≥1 postbaseline disease assessment.
P value was calculated using the Cochran-Mantel-Haenszel χ2 test stratified based on study ID.
ITT population with 1 prior line of therapy.
P value was calculated using the Fisher exact test.
Also, the legend title for Figure 1 should read “Progression-free survival and overall survival based on the 24-month relapse cut-off in the pooled population” not “Pooled progression free and overall survival based on the 24 month cut-off.”
Page 394: in Table 3, under “POLLUX,” in the row “≥VGPR,” the footnote symbol for the P value under “Early relapse (<24 mos)” and “Late relapse (≥24 mos)” should be †, not ‡. The corrected Table 3 is shown below:
. | CASTOR . | |||||
---|---|---|---|---|---|---|
Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
D-Vd . | Vd . | P . | D-Vd . | Vd . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 47 | 36 | 72 | 73 | ||
ORR | 39 (83.0) | 26 (72.2) | .2415† | 70 (97.2) | 55 (75.3) | .0001† |
≥CR | 13 (27.7) | 4 (11.1) | .0657† | 39 (54.2) | 12 (16.4) | <.0001† |
sCR | 2 (4.3) | 0 | 16 (22.2) | 5 (6.8) | ||
CR | 11 (23.4) | 4 (11.1) | 23 (31.9) | 7 (9.6) | ||
≥VGPR | 31 (66.0) | 12 (33.3) | .0034† | 60 (83.3) | 34 (46.6) | <.0001† |
VGPR | 18 (38.3) | 8 (22.2) | 21 (29.2) | 22 (30.1) | ||
PR | 8 (17.0) | 14 (38.9) | 10 (13.9) | 21 (28.8) | ||
MR | 2 (4.3) | 2 (5.6) | 1 (1.4) | 6 (8.2) | ||
SD | 2 (4.3) | 7 (19.4) | 1 (1.4) | 10 (13.7) | ||
PD | 4 (8.5) | 1 (2.8) | 0 | 2 (2.7) | ||
NE | 0 | 0 | 0 | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 50 | 38 | 72 | 75 | ||
MRD-negative, n (%) | 5 (10.0) | 0 | .0669§ | 20 (27.8) | 3 (4.0) | <.0001§ |
. | CASTOR . | |||||
---|---|---|---|---|---|---|
Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
D-Vd . | Vd . | P . | D-Vd . | Vd . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 47 | 36 | 72 | 73 | ||
ORR | 39 (83.0) | 26 (72.2) | .2415† | 70 (97.2) | 55 (75.3) | .0001† |
≥CR | 13 (27.7) | 4 (11.1) | .0657† | 39 (54.2) | 12 (16.4) | <.0001† |
sCR | 2 (4.3) | 0 | 16 (22.2) | 5 (6.8) | ||
CR | 11 (23.4) | 4 (11.1) | 23 (31.9) | 7 (9.6) | ||
≥VGPR | 31 (66.0) | 12 (33.3) | .0034† | 60 (83.3) | 34 (46.6) | <.0001† |
VGPR | 18 (38.3) | 8 (22.2) | 21 (29.2) | 22 (30.1) | ||
PR | 8 (17.0) | 14 (38.9) | 10 (13.9) | 21 (28.8) | ||
MR | 2 (4.3) | 2 (5.6) | 1 (1.4) | 6 (8.2) | ||
SD | 2 (4.3) | 7 (19.4) | 1 (1.4) | 10 (13.7) | ||
PD | 4 (8.5) | 1 (2.8) | 0 | 2 (2.7) | ||
NE | 0 | 0 | 0 | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 50 | 38 | 72 | 75 | ||
MRD-negative, n (%) | 5 (10.0) | 0 | .0669§ | 20 (27.8) | 3 (4.0) | <.0001§ |
. | POLLUX . | |||||
---|---|---|---|---|---|---|
Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
D-Rd . | Rd . | P . | D-Rd . | Rd . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 74 | 74 | 73 | 68 | ||
ORR | 71 (95.9) | 55 (74.3) | .0002† | 66 (90.4) | 59 (86.8) | .4967† |
≥CR | 43 (58.1) | 11 (14.9) | <.0001† | 44 (60.3) | 30 (44.1) | .0558† |
sCR | 18 (24.3) | 2 (2.7) | 28 (38.4) | 16 (23.5) | ||
CR | 25 (33.8) | 9 (12.2) | 16 (21.9) | 14 (20.6) | ||
≥VGPR | 63 (85.1) | 31 (41.9) | <.0001† | 54 (74.0) | 49 (72.1) | .7987† |
VGPR | 20 (27.0) | 20 (27.0) | 10 (13.7) | 19 (27.9) | ||
PR | 8 (10.8) | 24 (32.4) | 12 (16.4) | 10 (14.7) | ||
MR | 1 (1.4) | 8 (10.8) | 1 (1.4) | 1 (1.5) | ||
SD | 2 (2.7) | 8 (10.8) | 5 (6.8) | 8 (11.8) | ||
PD | 0 | 2 (2.7) | 0 | 0 | ||
NE | 0 | 1 (1.4) | 1 (1.4) | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 75 | 77 | 74 | 69 | ||
MRD-negative, n (%) | 23 (30.7) | 3 (3.9) | <.0001§ | 26 (35.1) | 12 (17.4) | .0225§ |
. | POLLUX . | |||||
---|---|---|---|---|---|---|
Early relapse (<24 mos) . | Late relapse (≥24 mos) . | |||||
D-Rd . | Rd . | P . | D-Rd . | Rd . | P . | |
Response, n (%)∗ | ||||||
Patients evaluated, n | 74 | 74 | 73 | 68 | ||
ORR | 71 (95.9) | 55 (74.3) | .0002† | 66 (90.4) | 59 (86.8) | .4967† |
≥CR | 43 (58.1) | 11 (14.9) | <.0001† | 44 (60.3) | 30 (44.1) | .0558† |
sCR | 18 (24.3) | 2 (2.7) | 28 (38.4) | 16 (23.5) | ||
CR | 25 (33.8) | 9 (12.2) | 16 (21.9) | 14 (20.6) | ||
≥VGPR | 63 (85.1) | 31 (41.9) | <.0001† | 54 (74.0) | 49 (72.1) | .7987† |
VGPR | 20 (27.0) | 20 (27.0) | 10 (13.7) | 19 (27.9) | ||
PR | 8 (10.8) | 24 (32.4) | 12 (16.4) | 10 (14.7) | ||
MR | 1 (1.4) | 8 (10.8) | 1 (1.4) | 1 (1.5) | ||
SD | 2 (2.7) | 8 (10.8) | 5 (6.8) | 8 (11.8) | ||
PD | 0 | 2 (2.7) | 0 | 0 | ||
NE | 0 | 1 (1.4) | 1 (1.4) | 0 | ||
MRD (10–5)‡ | ||||||
Patients evaluated, n | 75 | 77 | 74 | 69 | ||
MRD-negative, n (%) | 23 (30.7) | 3 (3.9) | <.0001§ | 26 (35.1) | 12 (17.4) | .0225§ |
The early-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed <24 months after initiating their first line of therapy; the late-relapse subgroup included patients with 1 prior line of therapy who progressed or relapsed ≥24 months after initiating their first line of therapy.
ITT, intent-to-treat; MR, minimal response; NE, not evaluable; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease.
Response-evaluable population with 1 prior line of therapy. The response-evaluable population was defined as patients with a confirmed diagnosis of MM and measurable disease at the baseline or screening visit who received ≥1 administration of study treatment and had ≥1 postbaseline disease assessment.
P value was calculated using the Cochran-Mantel-Haenszel χ2 test.
ITT population with 1 prior line of therapy.
P value was calculated using the Fisher exact test.
Page 397: Under “Authorship” in the “Conflict-of-interest disclosure,” J.B.B. should be included as one of the employees of Janssen who owns stock in Johnson & Johnson; thus, the sentence at the end of this section that reads “J.B.B. declares no competing financial interests” should be deleted.
The title of the Supplemental data file should read “Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX.” The revised supplemental file is available in the online version of this erratum.