Demographics and baseline characteristics
| Characteristic . | Patients (n = 28) . |
|---|---|
| Age | |
| Median (range), years | 67.5 (35-83) |
| Category, n (%) | |
| <65 years | 12 (42.9) |
| ≥65 years | 16 (57.1) |
| Male, n (%) | 16 (57.1) |
| Race, n (%) | |
| White | 25 (89.3) |
| Black/African American | 2 (7.1) |
| Unknown | 1 (3.6) |
| ECOG performance status,*n (%) | |
| 0 | 7 (25.0) |
| 1 | 18 (64.3) |
| 2 | 3 (10.7) |
| Time from diagnosis | |
| Median (range), days | 59.5 (15-501) |
| Involved organs, n (%) | |
| Median, n (range) | 2 (1-4) |
| ≥2 organs | 19 (67.9) |
| Kidney | 19 (67.9) |
| Heart | 17 (60.7) |
| Nerve | 6 (21.4) |
| Gastrointestinal tract | 5 (17.9) |
| Peripheral nervous system | 5 (17.9) |
| Liver | 4 (14.3) |
| Soft tissue | 4 (14.3) |
| Autonomic nervous system | 1 (3.6) |
| FLC isotype, n (%) | |
| Λ | 21 (75.0) |
| κ | 7 (25.0) |
| Immunoglobin heavy chain isotype, n (%) | N = 27 |
| Any heavy chain expression | 10 (37.0) |
| IgG | 8 (29.6) |
| IgA | 2 (7.4) |
| Mayo Clinic cardiac stage,†n (%) | |
| I | 6 (21.4) |
| II | 16 (57.1) |
| IIIa | 5 (17.9) |
| IIIb‡ | 1 (3.6) |
| NYHA class,§n (%) | |
| I | 17 (60.7) |
| II | 10 (35.7) |
| IIIA | 1 (3.6) |
| Baseline creatinine clearance, n (%) | |
| n | 27 |
| ≥60 mL/minute | 20 (74.1) |
| <60 mL/minute | 7 (25.9) |
| Characteristic . | Patients (n = 28) . |
|---|---|
| Age | |
| Median (range), years | 67.5 (35-83) |
| Category, n (%) | |
| <65 years | 12 (42.9) |
| ≥65 years | 16 (57.1) |
| Male, n (%) | 16 (57.1) |
| Race, n (%) | |
| White | 25 (89.3) |
| Black/African American | 2 (7.1) |
| Unknown | 1 (3.6) |
| ECOG performance status,*n (%) | |
| 0 | 7 (25.0) |
| 1 | 18 (64.3) |
| 2 | 3 (10.7) |
| Time from diagnosis | |
| Median (range), days | 59.5 (15-501) |
| Involved organs, n (%) | |
| Median, n (range) | 2 (1-4) |
| ≥2 organs | 19 (67.9) |
| Kidney | 19 (67.9) |
| Heart | 17 (60.7) |
| Nerve | 6 (21.4) |
| Gastrointestinal tract | 5 (17.9) |
| Peripheral nervous system | 5 (17.9) |
| Liver | 4 (14.3) |
| Soft tissue | 4 (14.3) |
| Autonomic nervous system | 1 (3.6) |
| FLC isotype, n (%) | |
| Λ | 21 (75.0) |
| κ | 7 (25.0) |
| Immunoglobin heavy chain isotype, n (%) | N = 27 |
| Any heavy chain expression | 10 (37.0) |
| IgG | 8 (29.6) |
| IgA | 2 (7.4) |
| Mayo Clinic cardiac stage,†n (%) | |
| I | 6 (21.4) |
| II | 16 (57.1) |
| IIIa | 5 (17.9) |
| IIIb‡ | 1 (3.6) |
| NYHA class,§n (%) | |
| I | 17 (60.7) |
| II | 10 (35.7) |
| IIIA | 1 (3.6) |
| Baseline creatinine clearance, n (%) | |
| n | 27 |
| ≥60 mL/minute | 20 (74.1) |
| <60 mL/minute | 7 (25.9) |
ECOG, Eastern Cooperative Oncology Group; NYHA, New York Heart Association.
ECOG performance status is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
Based on the European Modification of the Mayo staging system39 ; cardiac stage was based on 2 biomarker risk factors: NT-proBNP and high sensitivity cardiac troponin.
One patient with values corresponding to IIIa during screening subsequently increased to IIIb on cycle 1 day 1.
NYHA classification class I patients have no limitation during ordinary physical activity, class II patients have slight limitation during ordinary physical activity, class IIIA patients have symptoms with less than ordinary physical activity, class IIIb patients have symptoms with daily living activities, and class IV patients have symptoms at rest.42 Patients with class IIb or IV disease were excluded from the study.