Table 1.
Demographic and clinical characteristics in the intention-to-treat population at baseline.
| Characteristic | C-Rd Group (n = 143) | Rd Group (n = 143) | ||
|---|---|---|---|---|
| Age | ||||
| Median (range)—yr | 75 (65–91) | 76 (65–93) | ||
| Distribution—no. (%) | ||||
| <75 yr | 65 (45.5) | 59 (41.3) | ||
| ≥75 yr | 78 (54.5) | 84 (58.7) | ||
| Sex—no. (%) | ||||
| Male | 71 (49.7) | 64 (44.8) | ||
| Female | 72 (50.3) | 79 (55.2) | ||
| ECOG performance status—no. (%) | ||||
| 0 | 36 (25.9) | 41 (29.3) | ||
| 1 | 68 (48.9) | 66 (47.1) | ||
| 2 | 33 (23.7) | 29 (20.7) | ||
| ISS disease stage—no. (%) | ||||
| I | 36 (25.1) | 33 (23.0) | ||
| II | 53 (37.0) | 59 (41.2) | ||
| III | 54 (37.7) | 51 (35.6) | ||
| R-ISS disease stage—no. (%) | ||||
| I | 15 (12.8) | 17 (14.4) | ||
| II | 79 (67.5) | 83 (70.3) | ||
| III | 23 (19.6) | 18 (15.2) | ||
| Type of measurable disease—no. (%) | ||||
| IgG | 74 (52.1) | 84 (58.7) | ||
| IgA | 47 (33) | 37 (25.8) | ||
| Bence Jones | 21 (14.7) | 17 (11.8) | ||
| Cytogenetic profile—no./total no. (%) | ||||
| Standard risk | 106/131 (80.9) | 108/130 (83.1) | ||
| High risk | 25/131 (19.1) | 22/130 (16.9) | ||
The intention-to-treat population was defined as all the patients who underwent randomization.
Eastern Cooperative Oncology Group (ECOG) performance status is scored from 0 to 5, with 0 reflecting no disability and higher scores indicating increasing disability.
The International Staging System (ISS) disease stage, which is obtained on the basis of the combination of serum β2-microglobulin and albumin levels, consists in three stages: I (β2-microglobulin <3.5 mg/L and albumin ≥3.5 g/dL), II (neither stage I nor stage III) and III (β2-microglobulin ≥ 5.5 mg/L). Higher stages indicate more advanced disease.
The R-ISS is obtained on the basis of the combination of ISS, chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization after CD138 plasma cell purification and serum lactate dehydrogenase (LDH). R-ISS I includes ISS stage I, no high-risk CA [del(17p) and/or t(4;14) and/or t(14;16)], and normal LDH level (less than the upper limit of normal range); R-ISS III including ISS stage III and high-risk CA or high LDH level; and R-ISS II, including all other possible combinations.
Other types include IgD (one case), IgM (one case), non-secretory (two cases), and biclonal (one case).
Cytogenetic risk was based on the results of fluorescence in situ hybridization performed on CD138 + enriched bone marrow samples obtained at diagnosis.
High risk was defined by the presence of at least one of the following abnormalities: del17p, t(4;14), or t(14;16).