Lenalidomide (Revlimid) could potentially offer clinical benefits to patients with multiple myeloma.
Celgene Corporation recently announced results from 2 clinical studies examining the use of lenalidomide (Revlimid) in patients with multiple myeloma. These results were discussed at the 58th American Society of Hematology Annual Meeting.
Revlimidplus dexamethasone is currently indicated in patients with multiple myeloma. It is also indicated as a monotherapy in patients with anemia and certain cancers, according to a press release from Celgene.
In the Myeloma XI trial, investigators evaluated investigational Revlimid maintenance treatment against no maintenance treatment in newly-diagnosed patients. Both transplant-eligible and transplant non-eligible patients were included.
All patients received treatment with Revlimid or thalidomide plus cyclophosphamide and dexamethasone, according to Celgene. Transplant-eligible patients then received melphalan 200-mg/m2 autologous stem cell transplant, and then were randomized to receive maintenance Revlimid or observation after achieving maximum response.
The primary endpoint, which was progression-free survival (PFS), was 30 months in patients receiving Revlimid (n=857) compared with 18 months for patients under observation (n=694). For transplant-eligible patients, median PFS was 50 months for those taking Revlimid, and 28 months for those under observation.
In transplant non-eligible patients, the median PFS was 24 months for those taking Revlimid, and 11 months for those under observation, according to Celgene.
Serious adverse events for patients receiving Revlimid included neutropenia, thrombocytopenia, and anemia. Second primary malignancies were found in 72 patients, 24 in the observation cohort and 48 in the Revlimid cohort.
"The Myeloma XI study provides important insights for the continued investigation of lenalidomide as a maintenance treatment for people living with multiple myeloma," said Gareth Morgan, MD, PhD, director of the Myeloma Institute at the University of Arkansas for Medical Sciences. "Building on previous studies, lenalidomide maintenance in this study delayed relapse in patients compared to no maintenance."
In the phase 3 StaMINA Study, transplant-eligible patients were randomized after transplant to receive 4 cycles of Revlimid-bortezomib-dexamethasone (RVD) consolidation (n=254), tandem melphalan 200-mg/m2 autologous stem cell transplant consolidation (n=247), or no consolidation (n=257), according to the press release.
All patients received Revlimid maintenance therapy.
At 38 months, all patient groups had comparable progression-free and overall survival. The investigators found that a single stem cell transplant followed by Revlimid treatment was just as effective as the addition of RVD consolidation.
There were 36 patients who developed a total of 39 secondary primary malignancies across treatment arms.
"The StaMINA trial demonstrated that the addition of RVD consolidation or a second autologous stem cell transplant did not provide a superior outcome, on average, to a single autologous stem cell transplant followed immediately by lenalidomide maintenance," said Edward Stadtmauer, MD, section chief, Hematologic Malignancies at the University of Pennsylvania School of Medicine. "As transplants continue to be an option for many myeloma patients, these are important insights for determining the path to subsequent maintenance therapy."