Early intervention with an immunotherapy-based drug combination may prevent progression of high-risk “smoldering” multiple myeloma to the full-blown disease, according to researchers from Dana-Farber Cancer Institute.
The interim results of a phase 2 clinical trial are to be presented at the 58th annual meeting of the American Society of Hematology in San Diego on December 5, 2016. According to Irene Ghobrial, MD, first author of the report, the findings represent “a promising starting point for the paradigm shift towards early therapeutic intervention in patients with high-risk smoldering multiple myeloma.” Ghobrial is also co-principal investigator of the Center for Prevention of Progression of Blood Cancers at Dana-Farber/Brigham and Women’s Cancer Center.
The combination of the immunotherapy agent elotuzumab with lenalidomide and dexamethasone was well tolerated, with a low rate of grade 3 or 4 toxicities, the study found.
Individuals are said to have smoldering multiple myeloma if they have evidence of disease in the bone marrow and other pathological signs putting them at risk of developing myeloma, the incurable blood cancer diagnosed in about 30,000 people annually, with 12,650 deaths expected in 2016, according to the American Cancer Society.
Smoldering multiple myeloma patients with high-risk indicators have a 50 percent chance of progressing to symptomatic multiple myeloma within two years. A number of clinical trials are evaluating whether early intervention during the smoldering phase is safe and can prevent myeloma progression.
Ghobrial presented data on 47 of the 50 patients enrolled in the study to date, including 23 patients who completed nine treatment cycles. The drug combination caused tumor shrinkage in 82.6 percent of the latter group of patients, with 34.8 percent complete and very good partial responses.
“Many of these patients are in remission at a median follow-up time of seven months,” said Ghobrial. “Some patients have been followed for 23 months, and we haven’t seen progression to symptomatic disease in any patient.”
“The early results suggest better results than those from a previous trial in which patients received a combination of lenalidomide and dexamethasone,” said Ghobrial. “While the interim results are very exciting, I think we need a randomized phase 3 trial before we can make [early intervention] the standard of care.”
Senior authors of the report are Kenneth C. Anderson, MD, and Paul Richardson, MD, of Dana-Farber.