Evaluating Control Regimens in Phase III Clinical Trials for Early-Relapsed Multiple Myeloma

Sagar Lonial, MD, chief medical officer, Winship Cancer Institute of Emory University, discusses how phase III trials should be designed in the United States for patients with multiple myeloma in the early-relapse setting.

One of the most important pieces of information that separates practice in the United States and the way phase III clinical trials are designed is that most of these trials use lenalidomide (Revlimid) and dexamethasone as the control arm. However, Lonial argues that much of the data cannot be used because most patients progress on lenalidomide-based maintenance. Most of these data are irrelevant, except for in the case of a patient refusing or becoming intolerant to some form of lenalidomide maintenance.

Lonial suggests phase III trials look at using a proteasome inhibitor or pomalidomide (Pomalyst)—based salvage therapy for the control arm in these patients. These approaches are important because they are most relevant to the patient, he says. Currently, many physicians are using daratumumab (Darzalex) as a backbone and trying to figure out what would be the best agent to add, such as pomalidomide, bortezomib (Velcade), or carfilzomib (Kyprolis).