Myeloma Triple Combo Treatment Found Superior to Standard Therapy in Phase 3 Trial

Adding the proteasome inhibitor Velcade (bortezomib) to the standard therapy of Revlimid (lenalidomide) and dexamethasone — a triple combo therapy — significantly extends progression-free survival and overall survival of multiple myeloma patients, according to the results of a recent Phase 3 trial.

The study, titled “Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial,” was published in The Lancet.

In the randomized Phase 3 clinical trial (NCT00644228), investigators from SWOG, the international cancer clinical trials network funded by the National Cancer Institute (NCI), assessed the effectiveness of the triple combo therapy of Velcade, Revlimid, and dexamethasone in patients with previously untreated multiple myeloma.

A control group was treated with Revlimid and dexamethasone alone.

Between April 2008 and February 2012, 525 patients were randomly assigned to receive either an initial treatment of Velcade with Revlimd and dexamethasone (VRd) or Revlimd and dexamethasone alone (Rd group). The VRd regimen was given in eight 21-day cycles, while the Rd regimen was given in six 28-day cycles.

Results showed that the median progression-free survival was significantly improved in the VRd group (43 months), compared to 30 months in the Rd group. Median overall survival was also significantly higher in the VRd group compared to the Rd group (75 months vs. 64 months), the researchers reported.

The rates of overall response (partial response or better) were 82 percent in the VRd group, and 72 percent in the Rd group. In particular, the complete response rate in the VRd group was double that seen in Rd treated patients (16 percent vs. 8 percent).

“There’s a lot of excitement about these research findings and this treatment option, which helps myeloma patients stay healthier longer and gives them more time to spend with people they love,” SWOG study principal investigator Brian G.M. Durie, MD, of Cedars-Sinai Outpatient Cancer Center in Los Angeles and chairman of the board at the International Myeloma Foundation, said in a news release.

“Because the research was so solid, and the findings so strong, we’re looking at a potential new standard of care,” Durie said.

These results were presented in December at the 57th Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.