MULTIPLE MYELOMA

The FDA has granted a priority review designation to daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy. 

Based on findings from the phase III TOURMALINE-MM1 study, the Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval for ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.

<p>A set of guidelines for treating patients with relapsed and refractory multiple myeloma published by the International Myeloma Working Group may not aid&nbsp;researchers in identifying ideal treatment paths for those with relapsed and refractory disease until more genomic data has been gathered.</p>

This article reviews some of the concepts surrounding the diagnosis of multiple myeloma are still evolving, and are thus shaping how we see and manage multiple myeloma - hopefully moving slowly but surely toward its elusive cure.

Sundar Jagannath, MD, director, Multiple Myeloma Program, Tisch Cancer Institute at Mount Sinai Hospital, discusses the role of stem-cell transplant in the management of multiple myeloma.

Daratumumab (Darzalex) has been granted a breakthrough therapy designation by the FDA for use in the treatment of patients with multiple myeloma following at least 1 prior therapy. The CD38-targeted antibody is accepted for use in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone, according to Janssen, which is developing daratumumab with Genmab.

The therapeutic armamentarium for multiple myeloma is ever expanding, according to Sundar Jagannath, MD.

Substantial changes were made to the latest version of the NCCN guideline for multiple myeloma to address the multitude of newly approved agents for patients with this disease.

Daratumumab (Darzalex), when added to the standard two-drug regimen of bortezomib and dexamethasone, reduced the risk of progression or death by 61% compared with the standard regimen alone for patients with recurrent or refractory multiple myeloma.

A regimen consisting of carfilzomib (Kyprolis), pomalidomide (Pomalyst), and dexamethasone (KPd) merits further investigation for the treatment of patients with multiple myeloma whose disease progresses while on lenalidomide (Revlimid) in the earlier stages of disease.

The anti-CD38 monoclonal antibody isatuximab (SAR650984) showed promising signs of activity as a single-agent for patients with heavily pretreated relapsed/refractory multiple myeloma, according to updated findings from a phase II study presented at the 2016 ASCO Annual Meeting.

The role of APRIL/BCMA in multiple myeloma and the targeted agent BION-1301 is discussed by Kenneth Anderson, MD, PhD.

The high level of efficacy observed with the combination of bortezomib, lenalidomide, and dexamethasone in the phase III SWOG S0777 study significantly changed the frontline treatment paradigm for patients with multiple myeloma.

The all-oral triplet of ixazomib, lenalidomide, and dexamethasone improved progression-free survival by 5.9 months compared with lenalidomide and dexamethasone alone for patients with relapsed/refractory multiple myeloma.

Sagar Lonial, MD, discusses an ongoing phase III trial investigating if any interventions would change the natural history of smoldering myeloma.

Adding plitidepsin (Aplidin) to dexamethasone reduced the risk of disease progression by 35% versus dexamethasone alone in patients with relapsed/refractory multiple myeloma enrolled in the phase III ADMYRE trial.

John Leonard, MD, discusses the inefficacy of early treatment and treatment options for patients with follicular lymphoma. Leonard says the relapse rate for patients with follicular lymphoma is around 80%.

Sagar Lonial, MD, professor, School of Medicine, executive vice chair, Department of Hematology & Medical Oncology, chief medical officer, Winship Cancer Institute, Emory University, discusses whether or not to treat patients with smoldering multiple myeloma (SMM), or asymptomatic myeloma.

Captisol-enabled (CE) melphalan (Evomela) has been approved by the FDA as a high-dose conditioning treatment for patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).

For the first time, scientists have identified a "feed-forward loop" consisting of a gene, micro-RNA, and transcription factor implicated in both multiple myeloma and Waldenstrom's macroglobulinemia, according to an article published this month in the Blood Cancer Journal.

Branagan said in his study, which gave patients with myeloma a high-dose flu vaccine followed by a booster dose 30 days later, 66% of patients saw total serum protection from the ailment. he said previous efforts to vaccinate patients with myeloma has resulted in a 20% total serum protection.

Saad Usmani, MD, discusses newly approved treatments, as well as these combination therapies currently in clinical trials.

Data from the trial shows induction therapy with a triplet of bortezomib, lenalidomide, and dexamethasone improved both progression-free survival and overall survival over lenalidomide and dexamethasone alone in patients with untreated multiple myeloma.

Claire Harrison, MD, discusses ruxolitinib continuing to show a benefit for patients with advanced myelofibrosis over the course of a 5 year study.

S. Vincent Rajkumar, MD, discusses bortezomib, lenalidomide, and dexamethasone coming out on top in a recent phase III trial over lenalidomide and dexamethasone alone.