The FDA has released a statement regarding safety concerns that led to a clinical hold on three trials of pembrolizumab in combination with pomalidomide or lenalidomide for patients with multiple myeloma, and the active role of the FDA in protecting patient safety.
Prolonged use of bortezomib after treatment with combined bortezomib plus dexamethasone did not result in any significant benefit for patients with relapsed/refractory multiple myeloma compared with bortezomib plus dexamethasone alone, but this less dose-intensive approach could be a feasible option for patients who cannot tolerate the standard regimen.
Patients with newly diagnosed multiple myeloma treated with lenalidomide maintenance therapy after undergoing autologous stem-cell transplantation had significantly improved overall survival compared with observation or placebo.
The US Food and Drug Administration (FDA) placed a clinical hold on three trials of the PD-1 inhibitor pembrolizumab in combination with pomalidomide or lenalidomide for patients with multiple myeloma: KEYNOTE-183, KEYNOTE-185, and KEYNOT
Treatment with the combination of daratumumab plus pomalidomide/dexamethasone resulted in rapid, deep, and sustained responses with no new safety signals in patients with heavily treated multiple myeloma.
Undergoing autologous hematopoietic stem cell transplantation was effective and safe in patients with refractory multiple myeloma, including those patients who are refractory to both proteasome inhibitors and immunomodulatory agents.
Combining bendamustine, pomalidomide, and dexamethasone achieved a promising overall response rate in patients with heavily pretreated lenalidomide refractory multiple myeloma, according to the results of a phase I/II trial.