Table 2.
Treatment Exposurea
| Variable | Patients (n = 84) |
|---|---|
| PI therapy duration, including bortezomib-based induction,b mo | |
| Mean ± SD | 10.1 ± 5.6 |
| Medianc | 8.8 |
| Range | 2.6-26.4 |
| IRd therapy duration,d mo | |
| Mean ± SD | 7.3 ± 5.7 |
| Medianc | 6.1 |
| Range | 0.03-23.0 |
| Ixazomib therapy duration,e mo | |
| Mean ± SD | 7.0 ± 5.8 |
| Medianc | 5.1 |
| Range | 0.03-22.8 |
| Lenalidomide therapy duration,e mo | |
| Mean ± SD | 7.3 ± 5.7 |
| Medianc | 6.0 |
| Range | 0.03-23.0 |
| Relative dose intensity,f % (mean ± SD) | |
| Ixazomib | 77 ± 31 |
| Lenalidomide | 80 ± 89 |
| Dexamethasone | 85 ± 56 |
| Patients with no. of IRd treatment cycles, n (%) | |
| ≥3 | 67 (80) |
| ≥6 | 46 (55) |
| ≥12 | 19 (23) |
| ≥18 | 9 (11) |
| ≥24 | 1 (1) |
Abbreviations: IRd = ixazomib, lenalidomide, dexamethasone; PI = proteasome inhibitor; SD = standard deviation.
Patients had to continue receiving ixazomib to remain in the study; a dose interruption of ixazomib lasting > 3 weeks or an interruption at the principal investigator’s discretion was considered discontinuation from ixazomib treatment and the patient was discontinued from the study, although they could be followed for progression-free and overall survival. In addition, at the discretion of the treating physician, patients could discontinue treatment from lenalidomide and/or dexamethasone but continue ixazomib treatment and remain in the study.
Time from the date of first administration of the bortezomib-based induction regimen to the date of the last administration of ixazomib, lenalidomide, or dexamethasone.
Simple median (ie, not determined using Kaplan-Meier method).
Time from the date of the first administration of IRd to the date of the last administration of ixazomib, lenalidomide, or dexamethasone.
Time from the date of the first administration of ixazomib, lenalidomide to the date of the last administration of ixazomib, lenalidomide.
Relative dose intensity for each study drug was defined as 100 × (total amount of dose taken)/(total prescribed dose of treated cycles), where the total prescribed dose equaled the (dose prescribed at enrollment × the number of prescribed doses per cycle × the number of treated cycles).