0000000000300716
AUTHOR
Miguel T. Hernandez
Randomized Trial of Lenalidomide and Dexamethasone Versus Clarythromycin, Lenalidomide and Dexamethasone As First Line Treatment in Patients with Multiple Myeloma Not Candidates for Autologous Stem Cell Transplantation: Results of the GEM-Claridex Clinical Trial
Continuous treatment with lenalidomide (R) and dexamethasone (d) is a standard of care for multiple myeloma (MM) patients (pts) not candidates for autologous stem cell transplantation (ASCT). As previously reported, the addition of Clarithromycin (C) to Rd has proven to be safe and effective, and case-control analyses suggested a significant additive value with the combination. C optimizes the therapeutic effect of glucocorticoids by increasing the area under the curve, has immunomodulatory effects and may have direct antineoplastic properties. However, there are not randomized phase III trials confirming these results. GEM-Claridex in an open, randomized, phase III trial for untreated new…
Biological and clinical significance of dysplastic hematopoiesis in patients with newly diagnosed multiple myeloma
On behalf of the PETHEMA/GEM Cooperative Group.
Clinical Significance and Biomarkers to Predict Unsustained Complete Remission in Transplant-Eligible Multiple Myeloma
Background: Transplant-eligible MM patients are achieving unprecedented CR rates with frontline therapy. This urges the question about what other tests are informative upon a negative immunofixation (IFx-), as well as if patients with short duration CR continue having dismal survival with modern frontline plus salvage therapies and if so, how to predict risk of unsustained CR. Aim: To provide an optimal definition of unsustained CR and biomarkers to predict it in transplant-eligible MM patients treated with optimal therapy. Methods: A total of 262 patients enrolled in the PETHEMA/GEM2012MENOS65 trial and who were in CR after receiving six induction cycles of bortezomib, lenalidomide and dex…
Assessment of Treatment Response By Ife, Next Generation Flow Cytometry and Mass Spectrometry Coupled with Liquid Chromatography in the GEM2012MENOS65 Clinical Trial
Abstract Introduction : In patients (pts) with multiple myeloma (MM), next generation flow cytometry (NGF) and next generation sequencing have shown an increased capacity to identify the presence of disease and to anticipate patient's prognosis as compared to serum protein immunofixation (IFE). However, both methods rely on bone marrow (BM) samples and it is important to explore alternative techniques applicable in more accessible samples such as peripheral blood. Patients and Methods: Newly diagnosed MM pts enrolled in the PETHEMA/GEM2012MENOS65 trial received six cycles of induction with bortezomib, lenalidomide and dexamethasone (VRD), intensification with high-dose therapy (melphalan or…