Table 1.
Baseline Characteristics of the Patients.*
| Characteristic | RVD-Alone Group (N = 357) | Transplantation Group (N = 365) |
|---|---|---|
| Median age (IQR) — yr | 57 (25–66) | 55 (30–65) |
| Age category — no. (%) | ||
| <60 yr | 235 (65.8) | 263 (72.1) |
| ≥60 yr | 122 (34.2) | 102 (27.9) |
| Male sex — no. (%) | 202 (56.6) | 215 (58.9) |
| Race — no./total no. (%)† | ||
| White | 268/351 (76.4) | 272/359 (75.8) |
| Black | 66/351 (18.8) | 66/359 (18.4) |
| Asian | 8/351 (2.3) | 12/359 (3.3) |
| Other | 9/351 (2.6) | 9/359 (2.5) |
| Ethnic group — no./total no. (%)† | ||
| Hispanic | 19/355 (5.4) | 23/355 (6.5) |
| Non‑Hispanic | 336/355 (94.6) | 332/355 (93.5) |
| ECOG performance‑status score — no./total no. (%)‡ | ||
| 0 | 153/357 (42.9) | 164/364 (45.1) |
| 1 | 177/357 (49.6) | 161/364 (44.2) |
| 2 | 27/357 (7.6) | 39/364 (10.7) |
| Median BMI (IQR)§ | 28.5 (25.3–32.8) | 29.0 (25.5–32.8) |
| BMI — no. (%)§ | ||
| <25 | 80 (22.4) | 81 (22.2) |
| 25 to <30 | 141 (39.5) | 127 (34.8) |
| ≥30 | 136 (38.1) | 157 (43.0) |
| Type of multiple myeloma — no./total no. (%)¶ | ||
| IgG | 220/330 (66.7) | 200/337 (59.3) |
| IgA | 72/330 (21.8) | 95/337 (28.2) |
| Light chain only | 34/330 (10.3) | 41/337 (12.2) |
| Other | 4/330 (1.2) | 1/337 (0.3) |
| Serum β2‑microglobulin level — no./total no. (%) | ||
| <3.5 mg/liter | 211/357 (59.1) | 224/363 (61.7) |
| 3.5 to <5.5 mg/liter | 95/357 (26.6) | 91/363 (25.1) |
| ≥5.5 mg/liter | 51/357 (14.3) | 48/363 (13.2) |
| ISS disease stage — no. (%)‖** | ||
| I | 178 (49.9) | 184 (50.4) |
| II | 130 (36.4) | 134 (36.7) |
| III | 49 (13.7) | 47 (12.9) |
| Lactate dehydrogenase level — no./total no. (%) | ||
| Not elevated, <225 U/liter | 260/356 (73.0) | 270/362 (74.6) |
| Elevated, ≥225 U/liter | 96/356 (27.0) | 92/362 (25.4) |
| Cytogenetic risk category — no./total no. (%)**††‡‡ | ||
| High risk | 66/334 (19.8) | 66/340 (19.4) |
| Standard risk | 268/334 (80.2) | 274/340 (80.6) |
| Cytogenetic abnormalities — no./total no. (%)‡‡§§ | ||
| t(4;14) | 32/333 (9.6) | 28/340 (8.2) |
| t(14;16) | 10/333 (3.0) | 15/340 (4.4) |
| del17p | 38/333 (11.4) | 34/340 (10.0) |
| Other | 261/333 (78.4) | 272/340 (80.0) |
| Revised ISS disease stage — no./total no. (%)¶¶ | ||
| I | 103/333 (30.9) | 105/337 (31.2) |
| II | 202/333 (60.7) | 211/337 (62.6) |
| III‖‖ | 28/333 (8.4) | 21/337 (6.2) |
RVD therapy consists of lenalidomide, bortezomib, and dexamethasone. Percentages may not total 100 because of rounding. ASCT denotes autologous stem‑cell transplantation, and IQR interquartile range.
Race or ethnic group was reported by the patients.
Eastern Cooperative Oncology Group (ECOG) performance‑status scores range from 0 to 5, with higher numbers indicating greater disability.
The body‑mass index (BMI) is the weight in kilograms divided by the square of the height in meters.
The type of myeloma was not determined for 9 patients in the RVD‑alone group and 5 patients in the transplantation group, missing for 2 and 1, and not available owing to serum immunofixation–negative status in 16 and 22, respectively.
The International Staging System (ISS) consists of three stages: stage I, serum β2‑microglobulin level lower than 3.5 mg per liter (300 nmol per liter) and serum albumin level 3.5 g per deciliter or higher; stage II, neither stage I nor III; and stage III, serum β2‑microglobulin level 5.5 mg per liter or higher (≥470 nmol per liter). Higher stages indicate more severe disease.
This variable was a stratification factor.
A total of 23 patients in the RVD‑alone group and 25 patients in the transplantation group could not be evaluated by means of fluorescence in situ hybridization (FISH).
Cytogenetic risk was based on FISH or karyotype analysis; patients who had a high‑risk cytogenetic profile had at least one high‑risk abnormality (t[4;14], t[14;16], or del17p). Patients with standard risk had no high‑risk cytogenetic abnormalities.
Individual abnormalities were unknown for 1 patient in the RVD‑alone group. The “other” category includes patients in whom any other cytogenetic abnormality was reported but not those in whom no abnormalities were reported.
The revised ISS consists of three stages: stage I, serum β2‑microglobulin level lower than 3.5 mg per liter, serum albumin level of 3.5 g per deciliter or higher, an absence of high‑risk cytogenetic abnormalities, and a normal lactate dehydrogenase level (here defined as <225 U per liter); stage II, neither revised stages I or III; and stage III, serum β2‑microglobulin level 5.5 mg per liter or higher and high‑risk cytogenetic abnormalities or a high lactate dehydrogenase level (≥225 U per liter) or both. The revised ISS disease stage was not available for 24 patients in the RVD‑alone group and for 28 patients in the transplantation group because 23 patients in the RVD‑alone group and 25 patients in the transplantation group could not be evaluated by means of FISH and the lactate dehydrogenase level was missing in 1 patient in the RVD‑alone group and in 3 patients in the transplantation group.
Among the 49 patients with stage III disease, 8 (16%) had a t(4;14) translocation, 2 (4%) had a t(14;16) translocation, 11 (22%) had a 17p deletion, and 36 (73%) had an elevated lactate dehydrogenase level.