Demographic Characteristics and Hematology Measurements at Randomization
| . | CD34 Selected Arm (n = 67) . | Unselected Arm (n = 64) . | P Value . |
|---|---|---|---|
| Sex | |||
| Male | 37 (55%) | 47 (73%) | .030 |
| Female | 30 (45%) | 17 (27%) | |
| Age (yr) | |||
| Median | 51 | 52 | .852 |
| Range | 37-70 | 34-68 | |
| Karnofsky performance status | |||
| 70-89 | 18 (28%) | 14 (23%) | .577 |
| 90-100 | 47 (72%) | 46 (77%) | |
| Disease status | |||
| Complete remission | 5 (8%) | 10 (16%) | .175 |
| Partial remission | 46 (69%) | 38 (59%) | |
| Stable disease | 16 (24%) | 16 (25%) | |
| Years since first histopathologic diagnosis | |||
| Median | 0.5 | 0.5 | .874 |
| Range | 0.2-3.3 | 0.2-2.9 | |
| β-2 Microglobulin (mg/L) | |||
| Median | 1.7 | 2.0 | .161 |
| Range | 0.3-7.3 | 0.7-5.0 | |
| C-Reactive protein (mg/dL) | |||
| Median | 0.4 | 0.3 | .931 |
| Range | 0.3-2.7 | 0.3-5.4 | |
| No. of cycles of chemotherapy | |||
| Median | 4 | 4 | .958 |
| Range | 2-9 | 2-9 | |
| WBC (×103/μL) | |||
| Mean ± SEM | 24.6 ± 2.6 | 32.5 ± 2.8 | .042 |
| Median | 15.9 | 26.2 | |
| Range | 1.0-89.3 | 3.9-95.1 | |
| Platelets (×103/μL) | |||
| Mean ± SEM | 115.7 ± 7.1 | 148.5 ± 7.7 | .002 |
| Median | 110 | 152 | |
| Range | 17-275 | 28-309 |
| . | CD34 Selected Arm (n = 67) . | Unselected Arm (n = 64) . | P Value . |
|---|---|---|---|
| Sex | |||
| Male | 37 (55%) | 47 (73%) | .030 |
| Female | 30 (45%) | 17 (27%) | |
| Age (yr) | |||
| Median | 51 | 52 | .852 |
| Range | 37-70 | 34-68 | |
| Karnofsky performance status | |||
| 70-89 | 18 (28%) | 14 (23%) | .577 |
| 90-100 | 47 (72%) | 46 (77%) | |
| Disease status | |||
| Complete remission | 5 (8%) | 10 (16%) | .175 |
| Partial remission | 46 (69%) | 38 (59%) | |
| Stable disease | 16 (24%) | 16 (25%) | |
| Years since first histopathologic diagnosis | |||
| Median | 0.5 | 0.5 | .874 |
| Range | 0.2-3.3 | 0.2-2.9 | |
| β-2 Microglobulin (mg/L) | |||
| Median | 1.7 | 2.0 | .161 |
| Range | 0.3-7.3 | 0.7-5.0 | |
| C-Reactive protein (mg/dL) | |||
| Median | 0.4 | 0.3 | .931 |
| Range | 0.3-2.7 | 0.3-5.4 | |
| No. of cycles of chemotherapy | |||
| Median | 4 | 4 | .958 |
| Range | 2-9 | 2-9 | |
| WBC (×103/μL) | |||
| Mean ± SEM | 24.6 ± 2.6 | 32.5 ± 2.8 | .042 |
| Median | 15.9 | 26.2 | |
| Range | 1.0-89.3 | 3.9-95.1 | |
| Platelets (×103/μL) | |||
| Mean ± SEM | 115.7 ± 7.1 | 148.5 ± 7.7 | .002 |
| Median | 110 | 152 | |
| Range | 17-275 | 28-309 |
Demographic characteristics were evaluated for all patients in the intent-to-treat population. Comparability between arms was assessed by χ2 tests for sex, Karnofsky performance status, and disease status at registration and by two-sample t-tests for age, β-2 microglobulin at registration, and time (years) from first histopathologic diagnosis to date of randomization. Comparability between arms was assessed by the Wilcoxon rank sum test for C-reactive protein at registration and the number of cycles of prior chemotherapy. Hematology measurements were evaluated at time of randomization. Two-sample t-tests were used to compare the treatment arms with respect to the hematology measurements. The mean WBC count and mean platelet count at randomization were significantly lower in the CD34 selected arm compared with the unselected arm.