Lenalidomide (Revlimid) For Maintenance Therapy Post Stem Cell Tranplantation In Multiple Myeloma: Two Studies
Multiple myeloma patients would not need any introduction to Revlimid/lenalidomide, one of the novel drug agents used in treating the condition. Lenalidomide is being increasingly used as maintenance therapy post autologous stem cell transplantation in relapsed/refractory multiple myeloma patients. Let us take a look at two major studies that investigated the efficacy of using lenalidomide as maintenance therapy.
Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma (CALGB study), investigated whether lenalidomide maintenance therapy prolongs time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. The trial involved 460 patients of 71 years and below with stable disease/marginal/partial/complete response after 100 days of SCT. The patients were administered either lenalidomide or placebo until disease progression. The starting dose of lenalidomide was 10mg/day. The median time to disease progression in the lenalidomide group was found to be 46 months while the placebo group showed a median time of disease progression to be 27 months. The trial concluded that lenalidomide maintenance therapy initiated at 100 days after SCT showed significant longer time to disease progression and improved overall survival among patients. However, the toxicity and incidence of second cancers was higher with lenalidomide.
Another trial, Lenalidomide maintenance after stem-cell transplantation for multiple myeloma (IFM study), investigated the efficacy of lenalidomide maintenance therapy after transplantation. 614 patients (65 years and younger) with nonprogressive disease after first SCT were administered 10mg/day of lenalidomide (dose increased to 15mg/day if tolerated) or placebo until disease progression. The primary end point was progression free survival. It was found that use of lenalidomide as maintenance therapy post SCT showed an improved median progression-free survival of 41 months as against 23 months with placebo. Over 70% of the participants (of both groups) were alive at 4 years. However, post randomization, overall survival in both study groups was similar.
In yet another trial (MM-015) it was found that Revlimid can be used as maintenance therapy for refractory/relapsed multiple myeloma, however in this trial, participants did not have SCT as first line of therapy. Nevertheless, the trial results too concluded that lenalidomide maintenance therapy prolonged progression free survival.
Multiple myeloma is a rare cancer of the plasma cells in the bone marrow. Lenalidomide is an analog of thalidomide and functions by inhibiting tumor necrosis factor-alpha production. Lenalidomide is 50,000 more potent than thalidomide with less adverse drug reactions. Lenalidomide in combination with dexamethasone was found to be superior in treating relapsed/refractory multiple myeloma patients than treating with high doses of dexamethasone alone. Lenalidomide is approved by the FDA for use in combination with dexamethasone in patients with multiple myeloma who have received at least one prior therapy.