MULTIPLE MYELOMA

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses the STORM and STOMP clinical trials  in patients with multiple myeloma.

Multiple trials in Celgene’s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies, have been placed on clinical holds by the FDA.

Partial clinical holds have been placed on 3 trials by the FDA, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.

A look back at all the FDA news that occurred in the month of August.

The FDA recently released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.

A supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma has been accepted by the FDA.

Biochemical Progression of Stage II High-Risk Multiple Myeloma

Carfilzomib (Kyprolis) reduced the risk of death by 21% compared with bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, according to results from the phase III ENDEAVOR trial, now published in the<em> Lancet Oncology.</em>

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses the importance of partnering with a myeloma center when managing multiple myeloma.

Shaji Kumar, MD,&nbsp;discusses ixazomib, daratumumab triplets, denosumab, and CAR T-cell therapy in multiple myeloma.

Supplemental New Drug Applications were recently submitted in the United States and Europe for carfilzomib (Kyprolis). The sNDAs were submitted based on data from 2 phase III studies showing carfilzomib improves overall survival for patients with relapsed/refractory multiple myeloma. &nbsp;

The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone reduced the risk of death by 21% compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following prior treatment with 1 to 3 regimens.

Keith Stewart, MB, ChB, discusses treatment decisions centered around the care of patients with multiple myeloma, including the roles of autologous stem cell transplant and MRD testing.

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses CAR T-cell therapy for myeloma and other hematologic malignancies.

Multiple Myeloma With Symptomatic Progression