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. 2023 Jun 14;37(7):1521–1529. doi: 10.1038/s41375-023-01936-7

Table 1.

Patient demographics and baseline characteristics.

Isa-VRda
Part A Part B All
(n = 27) (n = 46) (n = 73)
Age, years
 Median (range) 71.0 (63–77) 70.0 (49–87) 71.0 (49–87)
Age group, n (%)
 <65 years 3 (11.1) 8 (17.4) 11 (15.1)
 ≥65–<75 years 17 (63.0) 30 (65.2) 47 (64.4)
 ≥75 years 7 (25.9) 8 (17.4)b 15 (20.5)
Male, n (%) 9 (33.3) 22 (47.8) 31 (42.5)
ECOG PS, n (%)
 0 16 (59.3) 23 (50.0) 39 (53.4)
 1 9 (33.3) 22 (47.8) 31 (42.5)
 2 2 (7.4) 1 (2.2) 3 (4.1)
ISS at study entry, n (%)
 Stage I 8 (29.6) 22 (47.8) 30 (41.1)
 Stage II 17 (63.0) 20 (43.5) 37 (50.7)
 Stage III 2 (7.4) 4 (8.7) 6 (8.2)
MM subtype, n (%)
 IgA 5 (18.5) 8 (17.4) 13 (17.8)
 IgD 0 1 (2.2) 1 (1.4)
 IgG 21 (77.8) 28 (60.9) 49 (67.1)
 Kappa light chain only 1 (3.7) 6 (13.0) 7 (9.6)
 Lambda light chain only 0 3 (6.5) 3 (4.1)
Measurable paraprotein at baselinec, n (%)
 Serum M-protein 18 (66.7) 28 (60.9) 46 (63.0)
 Urine M-protein 1 (3.7) 4 (8.7) 5 (6.8)
 Both serum and urine M-protein 5 (18.5) 8 (17.4) 13 (17.8)
 Kappa light chain 1 (3.7) 4 (8.7) 5 (6.8)
 Lambda light chain 1 (3.7) 2 (4.3) 3 (4.1)
Cytogenetic risk at study entry, n (%) n = 23 n = 31 n = 54
 Highd 3 (13.0) 8 (25.8) 11 (20.4)
 Standard 20 (87.0) 23 (74.2) 43 (79.6)
Molecular subtypes, n (%) present
 17p deletion (TP53) 1 (3.7) 4 (8.7) 5 (6.8)
 t(4;14) 2 (7.4) 4 (8.7) 6 (8.2)
 t(14;16) 0 0 0
 1q21+ 9 (33.3) 16 (34.8) 25 (34.2)
Median bone marrow plasma cells at study entry, % (range) 17.50 (2.5–90.0) 30.0 (4.0–92.0) 24.5 (2.5–92.0)
Soft tissue plasmacytoma at baseline, n (%) 0 2 (4.3) 2 (2.7)
Creatinine clearance, n (%)
 <60 mL/min/1.73 m2 6 (22.2) 3 (6.5) 9 (12.3)
  ≥30 to <60 mL/min/1.73 m2 6 (22.2) 3 (6.5) 9 (12.3)
  <50 mL/min/1.73 m2 1 (3.7) 2 (4.3) 3 (4.1)
 ≥60 mL/min/1.73 m2 21 (77.8) 42 (91.3) 63 (86.3)
 Missing 0 1 (2.2) 1 (1.4)

d dexamethasone, ECOG PS Eastern Cooperative Oncology Group performance status, Ig immunoglobulin, Isa isatuximab, ISS International Staging System, R lenalidomide, V bortezomib.

aFrom May 4, 2017, to April 20, 2018, 27 patients were enrolled in Part A (data cutoff April 5, 2021). From March 29, 2019, to January 27, 2020, 46 patients were enrolled in Part B (data cutoff January 28, 2022).

bOf these patients, 4 were >80 years old.

cMeasurable paraprotein at baseline based on C1D1 value.

dHigh-risk status was determined as having del17p or t(4;14) or t(14;16). Data were based on local FISH assessment when central data were not available for del17p or t(4;14) or t(14;16) and 1q21+ abnormalities. Five patients had combined cytogenetic abnormalities.

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