Table 1. Baseline characteristics of patients enrolled in Total Therapy protocols TT2 (TT2−Thal; TT2+Thal) and TT3.
| Factor | Combined | TT2 −Thal | TT2 +Thal | TT3a | TT3b | P-value |
|---|---|---|---|---|---|---|
| Age ⩾65 years | 266/1148 (23%) | 72/345 (21%) | 64/323 (20%) | 84/303 (28%) | 46/177 (26%) | 0.062 |
| Female | 451/1148 (39%) | 135/345 (39%) | 137/323 (42%) | 110/303 (36%) | 69/177 (39%) | 0.482 |
| White | 1035/1148 (90%) | 309/345 (90%) | 293/323 (91%) | 270/303 (89%) | 163/177 (92%) | 0.704 |
| Albumin <3.5 g/dl | 280/1144 (24%) | 59/343 (17%) | 60/321 (19%) | 80/303 (26%) | 81/177 (46%) | <0.001 |
| B2M >5.5 mg/l | 238/1146 (21%) | 63/345 (18%) | 59/323 (18%) | 65/303 (21%) | 51/175 (29%) | 0.023 |
| Creatinine ⩽1.5 mg/dl | 996/1148 (87%) | 293/345 (85%) | 279/323 (86%) | 267/303 (88%) | 157/177 (89%) | 0.548 |
| Creatinine >1.5 and ⩽2 mg/dl | 67/1148 (6%) | 20/345 (6%) | 21/323 (7%) | 14/303 (5%) | 12/177 (7%) | 0.706 |
| Creatinine >2 mg/dl | 85/1148 (7%) | 32/345 (9%) | 23/323 (7%) | 22/303 (7%) | 8/177 (5%) | 0.245 |
| CRP ⩾8 mg/l | 422/1137 (37%) | 127/339 (37%) | 136/319 (43%) | 100/302 (33%) | 59/177 (33%) | 0.063 |
| BL RC4a | 91/1148 (8%) | 36/345 (10%) | 24/323 (7%) | 23/303 (8%) | 8/177 (5%) | 0.103 |
| BL RC3a | 235/1148 (20%) | 68/345 (20%) | 69/323 (21%) | 60/303 (20%) | 38/177 (21%) | 0.925 |
| BL RC2a | 563/1148 (49%) | 169/345 (49%) | 157/323 (49%) | 153/303 (50%) | 84/177 (47%) | 0.928 |
| BL RC1a | 259/1148 (23%) | 72/345 (21%) | 73/323 (23%) | 67/303 (22%) | 47/177 (27%) | 0.539 |
| Hb <10 g/dl | 310/1147 (27%) | 80/345 (23%) | 81/322 (25%) | 94/303 (31%) | 55/177 (31%) | 0.070 |
| LDH ⩾190 U/l | 328/1146 (29%) | 98/344 (28%) | 106/322 (33%) | 81/303 (27%) | 43/177 (24%) | 0.168 |
| Platelet Count <150 × 109/l | 172/1147 (15%) | 54/345 (16%) | 54/322 (17%) | 38/303 (13%) | 26/177 (15%) | 0.493 |
| IgG isotype | 625/1148 (54%) | 186/345 (54%) | 177/323 (55%) | 173/303 (57%) | 89/177 (50%) | 0.542 |
| IgA isotype | 271/1148 (24%) | 77/345 (22%) | 84/323 (26%) | 72/303 (24%) | 38/177 (21%) | 0.617 |
| Bence Jones proteinuriab | 528/1122 (47%) | 155/339 (46%) | 134/318 (42%) | 141/300 (47%) | 98/165 (59%) | 0.004 |
| Light chain only | 214/1148 (19%) | 67/345 (19%) | 51/323 (16%) | 54/303 (18%) | 42/177 (24%) | 0.178 |
| Non-secretory disease | 22/1148 (2%) | 9/345 (3%) | 7/323 (2%) | 2/303 (1%) | 4/177 (2%) | 0.222 |
| Ratio of involved–uninvolved | n=570 | n=64 | n=62 | n=279 | n=165 | 0.107 |
| (n, median (range)) | 82 (2–255556) | 59 (2–18111) | 73 (3–5160) | 65 (2–142222) | 146 (2–255555) | |
| Cytogenetic abnormalities | 362/1127 (32%) | 104/339 (31%) | 93/322 (29%) | 95/293 (32%) | 70/173 (40%) | 0.065 |
| GEP 70 high risk | 123/795 (15%) | 20/176 (11%) | 26/175 (15%) | 40/276 (14%) | 37/168 (22%) | 0.052 |
| GEP PR subgroup | 111/795 (14%) | 27/176 (15%) | 24/175 (14%) | 33/276 (12%) | 27/168 (16%) | 0.606 |
Abbreviations: B2M, β-2-microglobulin; BL, baseline; CRP, C-reactive protein; eGFR, estimated glomerular filteration rate; GEP, gene expression profiling; Hb, hemoglobin; Ig, immunoglobulin; LDH, lactate dehydrogenase; n, number with factor, N, number with valid data for factor; ND, no valid observations for factor; PR, proliferation; RC, renal classes; Thal, thalidomide. P-value is from chi-squared test for binary variables; P-value is from Kruskal–Wallis test for continuous variables.
a
RC1 (eGFR ⩾90 ml/min/1.73 m2), RC2 (eGFR 60–89 ml/min/1.73 m2), RC3 (eGFR 30–59 ml/min/1.73 m2) and RC4 (eGFR <30 ml/min/1.73 m2).
b
M protein is present in urine (regardless of heavy-chain or light-chain types). Bold is always associated with P-value <0.05.