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Published on: October 27, 2014
Results from AMBER, a randomized phase 2 study of bevacizumab and bortezomib versus bortezomib in relapsed or
Darrell White1, Adetola Kassim, Birbal Bhaskar
1Division of Hematology, Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada. d.white@dal.ca
Background:
Newer systemic therapies have significantly advanced the treatment of multiple myeloma, but additional agents are needed. Bortezomib is a proteasome inhibitor with efficacy in relapsed/refractory multiple myeloma that inhibits tumor angiogenesis, a process that has been implicated in multiple myeloma pathogenesis.
Methods:
In AMBER("A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma"), patients with relapsed or refractory multiple myeloma were randomized to receive bortezomib (1.3 mg/m(2) on days 1, 4, 8, and 11 of each 21-day cycle) and either placebo or bevacizumab (15 mg/kg on day 1 of each cycle) for up to 8 cycles. At completion, patients in the bortezomib-plus-bevacizumab arm could continue bevacizumab until they developed progressive disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS).
Results:
The stratified hazard ratio of PFS for the bevacizumab-containing arm (n = 49) relative to the bortezomib monotherapy arm (n = 53) was 0.743 (95% confidence interval [CI], 0.43-1.28; P = .2804); the median PFS was 6.2 months (95% CI, 4.4-8.5 months) and 5.1 months (95% CI, 4.2-7.2 months), respectively; the overall response rates were 51% and 43.4% (P = .4029), respectively; and the median response duration was 6.9 months (95% CI, 4.73-11.83 months) and 6.0 months (95% CI, 4.86-8.31 months), respectively. Frequent adverse events occurred at similar rates across treatment arms, but hypertension, fatigue, and neuralgia occurred more frequently in the bevacizumab-containing arm.
Conclusions:
The addition of bevacizumab to bortezomib in unselected patients with pretreated multiple myeloma did not result in significant improvements in efficacy outcomes. The combination was well tolerated, and no new safety concerns for either agent were identified.
Insights
Adding bevacizumab to bortezomib did not significantly improve progression-free survival for multiple myeloma patients. The combination therapy was well-tolerated with no new safety concerns identified.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Multiple myeloma treatment has advanced with newer systemic therapies, yet additional agents are needed.
- Bortezomib, a proteasome inhibitor, shows efficacy in relapsed/refractory multiple myeloma and inhibits tumor angiogenesis.
- Tumor angiogenesis is implicated in the pathogenesis of multiple myeloma.
Purpose of the Study:
- To evaluate the efficacy and safety of bevacizumab in combination with bortezomib for patients with relapsed or refractory multiple myeloma.
- To assess the impact of adding bevacizumab to bortezomib on progression-free survival (PFS).
Main Methods:
- The AMBER study was a randomized, blinded, placebo-controlled, phase II trial.
- Patients received bortezomib plus either placebo or bevacizumab for up to 8 cycles.
- Progression-free survival (PFS) was the primary endpoint.
Main Results:
- The addition of bevacizumab did not significantly improve PFS (HR 0.743, P = .2804).
- Median PFS was 6.2 months with bevacizumab plus bortezomib versus 5.1 months with bortezomib alone.
- Overall response rates were 51% and 43.4%, respectively, with similar median response durations.
Conclusions:
- Bevacizumab added to bortezomib did not significantly improve efficacy outcomes in pretreated multiple myeloma patients.
- The combination of bevacizumab and bortezomib was well tolerated.
- No new safety concerns were identified for either agent when used in combination.
