Table 1.
ID | Age | Gender | Race | ISS Stage at screening | B2M | Cr | Revlimid exposed/refractory | Velcade exposed/refractory | Number of prior therapies | Number of prior lines of therapy | Cytogenetics at screening |
---|---|---|---|---|---|---|---|---|---|---|---|
DL1 | |||||||||||
A | 61 | F | C | 1 | 2.8 | 0.9 | Y/N | Y/N | 9 | 6 | ND |
B | 77 | M | C | 2 | 3.6 | 1.1 | Y/Y | Y/N | 7 | 7 | 5q+, 19p+, 11q22 tetrasomy |
C | 48 | M | C | 2 | 2.6 | 1.1 | Y/N | Y/N | 5 | 2 | 13.q14-, 5q+, 19p+, 11q22 tetrasomy, 1q21+ |
DL2 | |||||||||||
D | 48 | F | C | 3 | 8.1 | 1.7 | Y/N | Y/N | 7 | 6 | 13.q14-, 13q34-, 1q21+, 1q23+ |
E | 51 | F | C | 2 | 4.3 | 0.8 | Y/Y | Y/N | 9 | 8 | 17p13-, 13.q14-, 13q34- 1q21+, 1q23+, 1p36- |
F | 67 | M | C | 1 | 2.6 | 0.9 | Y/Y | Y/N | 5 | 1 | 17p13+, 5q+, 19p+, 11q22+, 1q+, t(11;14) |
G | 60 | M | C | 3 | 28.9 | 8.9 | Y/N | Y/Y | 10 | 9 | normal |
H | 55 | F | C | 2 | 1.8 | 0.3 | Y/Y | Y/N | 3 | 1 | normal |
I | 76 | M | C | 3 | 9.8 | 4.3 | Y/N | Y/N | 5 | 3 | normal |
J | 48 | M | C | 1 | 1.9 | 0.8 | Y/Y | Y/N | 5 | 1 | 5q+, 19p+ |
K | 61 | M | C | 2 | 5.3 | 1.9 | Y/N | Y/N | 5 | 4 | 13.q14-, 5q+, 19p+, 11q22+, 12p-, 1q21+, 1q23+, 1p36+ |
L | 62 | M | AA | 1 | 2.4 | 1.2 | Y/Y | Y/Y | 5 | 3 | 19p+, 11q22+, 12p-, 1q21+, 1q23+, 1p36+* |
Patient demographics of all patients enrolled on the phase 1 single agent Reolysin trial. Patient factors included age, gender, and race; ISS stage, beta-2 microglobulin, cytogenetics and serum creatinine at the time of screening; assessment of prior revlimid and/or velcade exposure, and number of prior therapies and lines of therapy. Abbreviations: B2M = beta-2 microglobulin at screening, Cr = serum creatinine at screening; ISS = International Staging System; F = female, M = male; Y = yes, N = no; C = Caucasian, AA = African American; NA = not applicable, ND = not determined; DL1 = dose level 1 (3 × 109 TCID50/day), DL2 = dose level 2 (3 × 1010 TCID50/day).