nse; VGPR = very good partial response
Eligible patients had 2 or more prior lines of therapy.
Per investigator assessment.
Exact confidence interval
Study 4
Study 4 was a single-arm, multicenter clinical trial of Kyprolis monotherapy by up to 10-minute infusion. Eligible patients were those with relapsed and refractory multiple myeloma who had received at least two prior therapies (including bortezomib and thalidomide and/or lenalidomide) and had ≤25% response to the most recent therapy or had disease progression during or within 60 days of the most recent therapy. Patients were excluded from the trial if they were refractory to all prior therapies or had a total bilirubin ≥ 2 ×ULN; creatinine clearance < 30 mL/min; New York Heart Association Class III to IV congestive heart failure; symptomatic cardiac ischemia; myocardial infarction within the last 6 months; peripheral neuropathy Grade 3 or 4, or peripheral neuropathy Grade 2 with pain; active infections requiring treatment; or pleural effusion.
Kyprolis was administered intravenously up to 10 minutes on two consecutive days each week for three weeks, followed by a 12-day rest period (28-day treatment cycle), until disease progression, unacceptable toxicity, or for a maximum of 12 cycles. Patients received 20 mg/m2 at each dose in Cycle 1, and 27 mg/m2 in subsequent cycles. Dexamethasone 4 mg orally or intravenously was administered prior to Kyprolis doses in the first and second cycles.
A total of 266 patients were enrolled. Baseline patient and disease characteristics are summarized in Table 19.
Table 19: Demographics and Baseline Characteristics in Study 4 (20/27 mg/m2 Monotherapy Regimen for Relapsed and Refractory Multiple Myeloma)
FISH = Fluorescence in situ hybridization; ISS = International Staging System
Range: 1, 20.
Categories for refractory status are derived by programmatic assessment using available laboratory data.
Efficacy was eva luated by ORR as determined by IRC assessment using IMWG criteria. The median number of cycles started was four. The ORR (PR or better) was 23% (95% CI: 18, 28) (see Table 20). The median DOR was 7.8 months (95%CI: 5.6, 9.2).
Table 20: Response Categories in Study 4 (20/27 mg/m2 Monotherapy Regimen)
CR = complete response; VGPR = very good partial response
Eligible patients had 2 or more prior lines of therapy and were refractory to the last regimen.
As assessed by the Independent Review Committee.
Exact confidence interval
Study 5
Study 5 was a single-arm, multicenter clinical trial of Kyprolis monotherapy by up to 10-minute infusion. Eligible patients were those with relapsed or refractory multiple myeloma who were bortezomib-naïve, had received one to three prior lines of therapy and had ≤ 25% response or progression during therapy or within 60 days after completion of therapy. Patients were excluded from the trial if they were refractory to standard first-line therapy or had a total bilirubin ≥ 2 × ULN; creatinine clearance < 30 mL/min; New York Heart Association Class III to IV congestive heart failure; symptomatic cardiac ischemia; myocardial infarction within the last 6 months; active infections requiring treatment; or pleural effusion.
Kyprolis was administered intravenously up to 10 minutes on two consecutive days each week for three weeks, followed by a 12-day rest period (28-day treatment cycle), until disease progression, unacceptable toxicity, or for a maximum of 12 cycles. Pat |
