Multiple Myeloma Drug Combination Improves Overall Survival

Addition of bortezomib to lenalidomide and low-dose dexamethasone therapy extends disease control.

A triple drug combination significantly improved disease control in the treatment of multiple myeloma during a recent clinical trial.

Adding bortezomib to the current standard of care in multiple myeloma of lenalidomide (Revlimid) and low-dose dexamethasone (RVd) significantly improved progression-free survival (PFS) versus lenalidomide and low-dose dexamethasone (Rd) in newly-diagnosed patients.

Data from the phase 3 study was presented at the 57th American Society of Hematology Annual Meeting.

Revlimid was previously approved in combination with dexamethasone to treat multiple myeloma, and in combination with dexamethasone for patients with multiple myeloma who received at least 1 prior therapy.

Revlimid was also previously approved for patients with mantle cell lymphoma whose disease relapsed or progressed after 2 prior therapies, 1 of which included bortezomib.

The phase 3 trial included 471 patients administered RVd, who achieved a median PFS of 43 months compared with a median PFS of 30 months in patients receiving Rd monotherapy [HR = 0.712, 96% CI, one-sided p=0.0018 (two-sided p=0.0037)].

Furthermore, patients administered RVd had a median overall survival (OS) of 75 months compared with a median of 64 months in patients administered Rd [HR=0.709, 96% CI, one-sided p=0.0125 (two-sided p=0.250)].

In terms of safety, grade 3 or higher adverse events by common toxicity criteria in patients receiving RVd versus Rd, respectively, included neurologic (33% vs. 11%), pain (12% vs. 4%), sensory (23% vs. 3%), and gastrointestinal (22% vs. 8%) events, according to Celgene, the manufacturer of Revlimid.

"This study is a great example of how new combinations are building on the backbone of myeloma research with Revlimid and low-dose dexamethasone," said Markus Renschler, MD, senior vice president and global head of Hematology & Oncology Medical Affairs for Celgene. "The study demonstrated that adding bortezomib to standard care Revlimid and dexamethasone improved remission rates and extended the duration of disease control."