Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma

Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point

“…1 However, the 3-year OS rates were similar among the treatment groups (70% in patients treated with MPR-R, 62% with MPR, and 66% with MP). 1 The MM-015 trial was completed before the EMA's proposal in December 2012 to include PFS2 as a clinical endpoint in trials of maintenance therapy. 10 Thus, PFS2 was not part of the original MM-015 study design, but was added as an exploratory, post hoc assessment.…”

“…[1][2][3][4][5][6][7][8] Increases in progression-free survival (PFS) and overall survival (OS) have been demonstrated in some trials of maintenance therapy, 4-6 but others have reported improved PFS with no corresponding improvement in OS. [1][2][3] The lack of OS benefit may be due to crossover and insufficient follow-up, as well as the fact that these trials were not powered to detect differences in OS between treatment groups. Theoretically, an experimental treatment may negatively affect OS (despite improving PFS) by increasing long-term toxicity or altering the tumor population or microenvironment to induce drug resistance or evolution of an aggressive clone.…”

“…1 In brief, 459 transplant-ineligible NDMM patients aged ≥65 years were randomized (1:1:1) to: melphalan, prednisone, lenalidomide (MPR) followed by lenalidomide maintenance (MPR-R) (nine 4-week cycles); MPR (nine 4-week cycles followed by placebo maintenance therapy); or melphalan and prednisone (MP) (nine 4-week cycles followed by placebo maintenance therapy). Maintenance therapy continued until disease progression or unacceptable toxicity.…”

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

“…[1][2][3] Immunomodulatory drugs (IMiDs; thalidomide and lenalidomide) and proteasome inhibitors (PIs; bortezomib) significantly improved survival in transplant-eligible and -ineligible patients. [4][5][6][7][8][9][10][11][12][13][14][15] Given the survival rate in transplant-ineligible patients and the substantial toxicity of high-dose melphalan (melphalan 200 mg/m 2 [MEL200]), the role of ASCT has become an area of debate, and the comparison with less toxic, oral novel agentsbased treatments a high research priority. Cyclophosphamide-lenalidomide-dexamethasone (CRD) showed a partial response rate of 85% and a good safety profile.…”

Risk of second primary malignancy in patients with AL amyloidosis treated with lenalidomide

“…SPM has been associated with radiation therapy, anthracyclines, alkylating agents, and topoisomerase inhibitors [3]. Recently an increased incidence of invasive SPM has been observed with lenalidomide (7.6%) compared with controls (2.9%) in patients with newly diagnosed myeloma receiving lenalidomide in combination with melphalan [4] or as long-term maintenance therapy following high-dose melphalan with autologous stem cell transplantation [5,6]. In a retrospective pooled analysis of 11 clinical trials of lenalidomide-based therapy for relapsed/refractory myeloma, the overall incidence rate (IR, events per 100 patient-years) of invasive SPM was 2.08 [7].…”