Table 3.
Comparisons of baseline values of patients with FLC reduction versus those without, median (range)
| Including only highest dose levels a | Including all dose levels | ||||
|---|---|---|---|---|---|
| 25% FLC reduction | No FLC reduction |
p | No FLC reduction | p b | |
| N | 4 | 7 | 27 | ||
| Baseline measles titer, Diamedex assay | 12 (6, 77.8) | 16.2 (3.2, 80) | NS | 13.95 (2.23, 90) | NS |
| Baseline measles titer, Neutralization assay | 10 (0, 20) | 10 (0, 80) | NS | 0 (0, 80) | NS |
| BMPC | 4.5 (1, 54) | 30 (4, 80) | NS | 40 (4, 100) | 0.04 |
| CD46 MFI of PC’s | 119 (44, 180) | 380 (192, 626) | 0.01 | 254(115, 626) | 0.01 |
| CD46/BMPC cell, (x1000) | 21.0 (0.06, 32.8) | 59.8 (17.4, 84.9) | 0.06 | 45.5 (15.1, 140.8) | 0.02 |
| CD46/ CD138- cells, (x1000) | 7.4 (1.0, 12.3) | 5.9 (5.5, 14.3) | NS | 101.1 (4.5, 14.3) | NS |
| SLAM, % | 49 (16, 100) | 9 (1, 57) | 0.03 | 7.35 (0.4, 97) | 0.05 |
| SLAM MFI BMPC | 38 (11, 135) | 37 (4, 76) | NS | 19.5 (3.1, 144) | NS |
| SLAM MFI CD138- cells | 6 (6, 16) | 8 (3, 10) | NS | 5.5 (2.4, 11) | NS |
| Day 15 N-gene in blood by Q-RT-PCR | 3,935 (0, 13039) | 2,928 (0, 18,400) | NS | 0 (0, 18,400) | 0.04 |
BMPC, bone marrow plasma cells; MFI, mean fluorescent intensity; BMPC, bone marrow plasma cells; NS, not significant
a
Stage I patients at TCID50 1010 and 1011
b
Comparator of “25% FLC reduction” group includes 5 patients, i.e. the 4 patients treated at 1011 TCID50 or higher and the one Stage II patient treated with CTX and only 107 TCID50