Table 1.
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.