Patient characteristics
| Characteristic . | Value (N = 35) . |
|---|---|
| Age, median (range), y | 70 (40-80) |
| Sex, n (%) | |
| Female | 19 (54) |
| Male | 16 (46) |
| ECOG performance status, n (%)∗ | |
| 0 | 8 (23) |
| 1 | 25 (71) |
| 2 | 2 (6) |
| Time from diagnosis to registration, median (range), mo | 19 (0.2-178) |
| Prior therapies, n (%)† | |
| PI | 33 (94) |
| Alkylator (separate from HD melphalan for ASCT) | 25 (71) |
| ASCT | 16 (46) |
| IMiD | 9 (23) |
| Anti-fibril monoclonal antibody | 3 (7) |
| Anti-CD38 monoclonal antibody | 2 (6) |
| Median bone marrow plasmacytosis (range), % | 6 (0-30) |
| Median baseline IgG level (range), mg/dL | 700 (141-1689) |
| Serum FLC, n (%) | |
| Lambda | 23 (66) |
| Kappa | 10 (29) |
| None | 1 (3) |
| Unknown | 1 (3) |
| Median dFLC (range), mg/dL‡ | 10.8 (4.6-92.4) |
| FISH studies, n (%)§ | |
| Normal | 7 (20) |
| t(11;14) | 10 (29) |
| t(4;14) | 3 (9) |
| Del 17p | 3 (9) |
| Other abnormality | 11 (31) |
| Insufficient material/not completed | 4 (11) |
| Organ involvement, n (%) | |
| Single organ involvement | 18 (51) |
| Multiple organ involvement | 17 (49) |
| Cardiac | 25 (71) |
| Renal | 14 (40) |
| Autonomic nervous system | 9 (26) |
| Soft tissue | 5 (14) |
| Gastrointestinal | 2 (6) |
| Liver | 1 (3) |
| European modification of Mayo biomarker stage, n (%)|| | |
| Stage I | 9 (26) |
| Stage II | 20 (57) |
| Stage IIIa | 1 (3) |
| N/A: missing data | 5 (14) |
| Characteristic . | Value (N = 35) . |
|---|---|
| Age, median (range), y | 70 (40-80) |
| Sex, n (%) | |
| Female | 19 (54) |
| Male | 16 (46) |
| ECOG performance status, n (%)∗ | |
| 0 | 8 (23) |
| 1 | 25 (71) |
| 2 | 2 (6) |
| Time from diagnosis to registration, median (range), mo | 19 (0.2-178) |
| Prior therapies, n (%)† | |
| PI | 33 (94) |
| Alkylator (separate from HD melphalan for ASCT) | 25 (71) |
| ASCT | 16 (46) |
| IMiD | 9 (23) |
| Anti-fibril monoclonal antibody | 3 (7) |
| Anti-CD38 monoclonal antibody | 2 (6) |
| Median bone marrow plasmacytosis (range), % | 6 (0-30) |
| Median baseline IgG level (range), mg/dL | 700 (141-1689) |
| Serum FLC, n (%) | |
| Lambda | 23 (66) |
| Kappa | 10 (29) |
| None | 1 (3) |
| Unknown | 1 (3) |
| Median dFLC (range), mg/dL‡ | 10.8 (4.6-92.4) |
| FISH studies, n (%)§ | |
| Normal | 7 (20) |
| t(11;14) | 10 (29) |
| t(4;14) | 3 (9) |
| Del 17p | 3 (9) |
| Other abnormality | 11 (31) |
| Insufficient material/not completed | 4 (11) |
| Organ involvement, n (%) | |
| Single organ involvement | 18 (51) |
| Multiple organ involvement | 17 (49) |
| Cardiac | 25 (71) |
| Renal | 14 (40) |
| Autonomic nervous system | 9 (26) |
| Soft tissue | 5 (14) |
| Gastrointestinal | 2 (6) |
| Liver | 1 (3) |
| European modification of Mayo biomarker stage, n (%)|| | |
| Stage I | 9 (26) |
| Stage II | 20 (57) |
| Stage IIIa | 1 (3) |
| N/A: missing data | 5 (14) |
Data cutoff: 30 December 2022.
ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; HD, high dose; IMiDs, immunomodulatory agents.
ECOG performance status scores range from 0 to 5, with 0 indicating no symptoms, and higher score indicating increasing disability.
Prior treatments included PIs, ASCT, and IMiDs.
Data are based on the difference between the involved and uninvolved serum FLC (dFLC).
FISH was utilized to identify chromosomal abnormalities. Percentages are not additive as patients can have >1 type of FISH abnormality. Other abnormalities included gain 1q, deletion 13q, other immunoglobulin heavy locus (IGH) abnormalities, gain 5, 9, and 19.
The European 2015 modification of the Mayo 2004 model was utilized for staging that included the NT-proBNP and troponin.