Table 1.
Baseline patient characteristics at study entry in the all-treated population.
| Isatuximab 20 mg/kg QW/Q2W (N = 32) | |
|---|---|
| Age (years) | |
| Median (range) | 70.5 (51–84) |
| <65 years, n (%) | 8 (25.0) |
| 65–74 years, n (%) | 14 (43.8) |
| ≥75 years, n (%) | 10 (31.3) |
| Median time from diagnosis to first dose, years (range) | 7.1 (1.2–19.4) |
| MM subtype, n (%) | |
| IgG | 13 (40.6) |
| IgA | 8 (25.0) |
| IgM | 0 (0) |
| Kappa light chain only | 6 (18.8) |
| Lambda light chain only | 5 (15.6) |
| ISS stagea, n (%) | |
| Stage I | 12 (37.5) |
| Stage II | 9 (28.1) |
| Stage III | 10 (31.3) |
| Unknown | 1 (3.1) |
| ECOG performance status, n (%) | |
| 0 | 5 (15.6) |
| 1 | 16 (50.0) |
| 2 | 10 (31.3) |
| 3 | 1 (3.1) |
| Cytogenetic riskb, n (%) | |
| High-risk CA | 5 (15.6) |
| Standard-risk CA | 8 (25.0) |
| Unknown or missing | 19 (59.4) |
| Number of prior lines of therapy | |
| Median (range) | 7.0 (2–14) |
| Number of prior lines by patient by category, n (%) | |
| <5 | 10 (31.3) |
| ≥5 | 22 (68.8) |
| Prior therapy, n (%) | |
| Alkylating agent | 31 (96.9) |
| IMiD agent | 31 (96.9) |
| PI agent | 32 (100) |
| PI and IMiD agent | 31 (96.9) |
| Dara | 32 (100) |
| Refractory status, n (%) | |
| IMiD refractory | 29 (90.6) |
| PI refractory | 26 (81.3) |
| PI and IMiD refractory | 24 (75.0) |
| Quad-refractory (RPVK) | 9 (28.1) |
| Penta-refractory (RPVK–Dara) | 9 (28.1) |
| Refractory to last line | 32 (100) |
| Refractory to Dara | 32 (100) |
| Number of Dara lines, n (%) | |
| 1 | 27 (84.4) |
| 2 | 4 (12.5) |
| 3 | 1 (3.1) |
| Dara therapy type, n (%) | |
| Monotherapy | 15 (46.9) |
| Combination therapy | 17 (53.1) |
| Duration of Dara treatment by category (months), n (%) | |
| <6 months | 14 (43.8) |
| ≥6 months | 18 (56.3) |
| Best response with Dara, n (%) | |
| Complete response | 3 (9.4) |
| Very good partial response | 7 (21.9) |
| Partial response | 10 (31.3) |
| Minimal response | 2 (6.3) |
| Stable disease | 6 (18.8) |
| Progressive disease | 4 (12.5) |
| Median time from last dose Dara to first Isa, weeks (range) | 13.07 (6–80.7) |
| <12 weeks | 14 (43.8) |
| ≥12 weeks | 18 (56.3) |
| <24 weeks | 20 (62.5) |
| ≥24 weeks | 12 (37.5) |
| <48 weeks | 27 (84.4) |
| ≥48 weeks | 5 (15.6) |
| Dara as last line prior to Isa, n (%) | 19 (59.4) |
CA chromosomal abnormalities, COPD chronic obstructive pulmonary disease, d dexamethasone, Dara daratumumab, ECOG Eastern Cooperative Oncology Group, Ig immunoglobulin, IMiD immunomodulatory drug, Isa isatuximab, ISS International Staging System, K carfilzomib, MM multiple myeloma, P pomalidomide, PI proteasome inhibitor, QW/Q2W once weekly for 4 weeks, then every other week, R lenalidomide, V bortezomib.
aISS staging was derived based on the combination of serum β2-microglobulin and albumin.
bHigh-risk CA was defined as the presence of del(17p), and/or t(4;14), and/or t(14;16) by fluorescence in situ hybridization. Cytogenetic analysis was performed by a central laboratory with a cut-off of 10% of analyzed plasma cells for del(17p), and 15% of analyzed plasma cells for t(4;14) and t(14;16).