Patient characteristics (N = 37)
| Characteristic . | Phase 1 . | Phase 2 . | All patients . |
|---|---|---|---|
| Male/female, n (%) | 6 (46%)/7 (54%) | 13 (54%)/11 (46%) | 19 (51%)/ 18 (49%) |
| Median age, y (range) | 68 (45-78) | 65 (48-82) | 68 (45-82) |
| Age > 65 y, n (%) | 9 (69%) | 12 (50%) | 21 (57%) |
| Untreated/pretreated, n (%) | 7 (54%)/6 (46%) | 17 (71%)/7 (29%) | 24 (65%)/13 (35%) |
| Previous therapies, n (%) | |||
| Thalidomide | 1 (8%) | 3 (13%) | 4 (11%) |
| Bortezomib | 4 (31%) | 1 (4%) | 5 (14%) |
| High-dose melphalan | 1 (8%) | 3 (13%) | 4 (11%) |
| Organ involvement, n (%) | |||
| Heart | 8 (62%) | 13 (54%) | 21 (57%) |
| Kidney | 8 (62%) | 16 (67%) | 24 (65%) |
| Liver | 2 (15%) | 1 (4%) | 3 (8%) |
| Nerve | 2 (15%) | 6 (25%) | 8 (22%) |
| Soft tissue | 4 (31%) | 6 (25%) | 10 (27%) |
| No. of involved organs, median (range) | 2 (1-4) | 2 (1-3) | 2 (1-4) |
| ≥ 2 organs involved, n (%) | 7 (54%) | 13 (54%) | 20 (54%) |
| NTproBNP, ng/L, median (range) | 2325 (36-9197) | 448 (59-9047) | 1046 (46-9197) |
| NTproBNP ≥ 332 ng/L, n (%) | 9 (69%) | 14 (58%) | 23 (62%) |
| Troponin T ≥ 0.035 ng/L, n (%) | 6 (46%) | 7 (29%) | 13 (35%) |
| Mayo Clinic stage, n (%) | |||
| I | 4 (31%) | 10 (42%) | 14 (38%) |
| II | 3 (23%) | 7 (29%) | 10 (27%) |
| III | 6 (46%) | 7 (29%) | 13 (35%) |
| Median IVS, mm (range) | 12 (9-23) | 13 (8-20) | 13 (8-23) |
| IVS ≥ 15 mm, n (%) | 5 (38%) | 6 (25%) | 11 (30%) |
| Symptoms of congestive heart failure, n (%) | 7 (54%) | 12 (50%) | 19 (51%) |
| New York Heart Association score ≥ 2, n (%) | 6 (46%) | 10 (42%) | 16 (43%) |
| ECOG performance status, n (%) | 6 (46%) | 9 (38%) | 15 (40%) |
| Median proteinuria, mg/d (range) | 1525 (100-17 000) | 4530 (0-21 000) | 2208 (0-21 000) |
| Median serum albumin, gr/dL (range) | 3.8 (1-6.4) | 3.45 (1.8-4.4) | 3.6 (1-6.4) |
| Median serum creatinine, mg/dL (range) | 0.9 (0.6-2.2) | 0.82 (0.45-1.99) | 0.9 (0.45-2.2) |
| Median eGFR,* mL/min/1.73m2 (range) | 75.9 (29-139) | 82.14 (26-210) | 81.6 (26-210) |
| eGFR < 30 mL/min/1.73m2, n (%) | 1 (8%) | 1 (4%) | 2 (5%) |
| Light chain type, κ/λ, n (%) | 1 (8%)/12 (92%) | 7 (29%)/17 (71%) | 8 (22%)/29 (78%) |
| Involved free light chain, mg/L (range) | 103 (26-3220) | 191 (15.8-6070) | 166 (15.8-6070) |
| Characteristic . | Phase 1 . | Phase 2 . | All patients . |
|---|---|---|---|
| Male/female, n (%) | 6 (46%)/7 (54%) | 13 (54%)/11 (46%) | 19 (51%)/ 18 (49%) |
| Median age, y (range) | 68 (45-78) | 65 (48-82) | 68 (45-82) |
| Age > 65 y, n (%) | 9 (69%) | 12 (50%) | 21 (57%) |
| Untreated/pretreated, n (%) | 7 (54%)/6 (46%) | 17 (71%)/7 (29%) | 24 (65%)/13 (35%) |
| Previous therapies, n (%) | |||
| Thalidomide | 1 (8%) | 3 (13%) | 4 (11%) |
| Bortezomib | 4 (31%) | 1 (4%) | 5 (14%) |
| High-dose melphalan | 1 (8%) | 3 (13%) | 4 (11%) |
| Organ involvement, n (%) | |||
| Heart | 8 (62%) | 13 (54%) | 21 (57%) |
| Kidney | 8 (62%) | 16 (67%) | 24 (65%) |
| Liver | 2 (15%) | 1 (4%) | 3 (8%) |
| Nerve | 2 (15%) | 6 (25%) | 8 (22%) |
| Soft tissue | 4 (31%) | 6 (25%) | 10 (27%) |
| No. of involved organs, median (range) | 2 (1-4) | 2 (1-3) | 2 (1-4) |
| ≥ 2 organs involved, n (%) | 7 (54%) | 13 (54%) | 20 (54%) |
| NTproBNP, ng/L, median (range) | 2325 (36-9197) | 448 (59-9047) | 1046 (46-9197) |
| NTproBNP ≥ 332 ng/L, n (%) | 9 (69%) | 14 (58%) | 23 (62%) |
| Troponin T ≥ 0.035 ng/L, n (%) | 6 (46%) | 7 (29%) | 13 (35%) |
| Mayo Clinic stage, n (%) | |||
| I | 4 (31%) | 10 (42%) | 14 (38%) |
| II | 3 (23%) | 7 (29%) | 10 (27%) |
| III | 6 (46%) | 7 (29%) | 13 (35%) |
| Median IVS, mm (range) | 12 (9-23) | 13 (8-20) | 13 (8-23) |
| IVS ≥ 15 mm, n (%) | 5 (38%) | 6 (25%) | 11 (30%) |
| Symptoms of congestive heart failure, n (%) | 7 (54%) | 12 (50%) | 19 (51%) |
| New York Heart Association score ≥ 2, n (%) | 6 (46%) | 10 (42%) | 16 (43%) |
| ECOG performance status, n (%) | 6 (46%) | 9 (38%) | 15 (40%) |
| Median proteinuria, mg/d (range) | 1525 (100-17 000) | 4530 (0-21 000) | 2208 (0-21 000) |
| Median serum albumin, gr/dL (range) | 3.8 (1-6.4) | 3.45 (1.8-4.4) | 3.6 (1-6.4) |
| Median serum creatinine, mg/dL (range) | 0.9 (0.6-2.2) | 0.82 (0.45-1.99) | 0.9 (0.45-2.2) |
| Median eGFR,* mL/min/1.73m2 (range) | 75.9 (29-139) | 82.14 (26-210) | 81.6 (26-210) |
| eGFR < 30 mL/min/1.73m2, n (%) | 1 (8%) | 1 (4%) | 2 (5%) |
| Light chain type, κ/λ, n (%) | 1 (8%)/12 (92%) | 7 (29%)/17 (71%) | 8 (22%)/29 (78%) |
| Involved free light chain, mg/L (range) | 103 (26-3220) | 191 (15.8-6070) | 166 (15.8-6070) |