Clinical efficacy for relapsed or refractory multiple myeloma1,2
The efficacy of DOXIL® + bortezomib was established in a randomized, open-label, international, multicenter study in 646 patients with multiple myeloma who had not previously received bortezomib and whose disease progressed during or after at least 1 prior therapy. Patients were randomized to receive DOXIL® + bortezomib or bortezomib alone.1
Primary endpoint: Time to progression (TTP)1
Secondary endpoints: Overall survival (OS), objective response rates (ORRs), and safety2
Patients who had not previously received bortezomib and whose multiple myeloma progressed during or after at least 1 prior therapy (N=646) were randomized to 2 study arms and were treated for up to 8 cycles or until disease progression or the occurrence of unacceptable toxicity.
Treatment plan 1,2
Patients were treated for up to 8 cycles or until disease progression or the occurrence of unacceptable toxicity.
Patients were prospectively stratified by β2-microglobulin level and then further stratified based on response to prior treatment (ie, relapsed or refractory).2
- Patients who maintained response were allowed to receive further treatment
- In both arms, the median number of cycles of therapy was 5 (range, 1-18)
*As the prespecified primary objective was achieved at the interim analysis, patients in the bortezomib monotherapy group were then allowed to receive the DOXIL® and bortezomib combination. The combination arm demonstrated significant improvement in time to progression.1
Baseline demographics and patient characteristics1
Time to progression (TTP) results1,2
Median TTP with DOXIL® + bortezomib was 9.3 months vs 6.5 months with bortezomib as monotherapy (P<0.001). TTP was defined as the time from randomization to the first occurrence of progressive disease or death due to progressive disease.1
TTP across patient types2
In nearly all subgroups, the hazard ratio for TTP favored the DOXIL® + bortezomib group and was consistent with the ITT population as a whole.
- Differences in effects of race were not assessed due to the limited number of Black and Asian patients in the study population
Additional endpoints in multiple myeloma1
No difference was observed in overall survival between the groups (33 months for DOXIL® + bortezomib vs 31 months for bortezomib monotherapy; HR=0.96 [95% CI, 0.80-1.14]).1
- The response rate reported for the DOXIL® + bortezomib group was 303 responses vs 310 responses in the bortezomib monotherapy group (P=0.25), as per EBMT criteria2
- 5% complete response (CR) in the DOXIL® + bortezomib group vs 3% in the bortezomib monotherapy group
- 43% partial response (PR) in the DOXIL® + bortezomib group vs 40% in the bortezomib monotherapy group
- 48% CR+ PR in the DOXIL® + bortezomib group vs 43% in the bortezomib monotherapy group
- The median duration of response was 10.2 months (95% CI, 10.2-12.9) with DOXIL® + bortezomib vs 7.0 months (95% CI, 5.9-8.3) with bortezomib alone
- Median survival was 33 months in the combination therapy group vs 31 months in the monotherapy group
DOXIL® (doxorubicin HCl liposome injection) Prescribing Information. Janssen Products, LP, Horsham, PA.
Data on file. Janssen Products, LP, Horsham, PA.
Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 2001;19(14):3312-3322.