Preliminary re­­sults from an on­go­ing Phase 1/2 clin­i­cal trial sug­gest that elotuzumab, in com­bi­na­tion with Revlimid (lena­lido­mide) and low-dose dexamethasone (Decadron), may have po­ten­tial in the treat­ment of mul­ti­ple myeloma. The findings were pre­sented at the American Society of He­ma­tol­ogy’s 51^st Annual Meeting at the beginning of last month.

Dr. Ravi Vij from the Uni­ver­sity of Washington in St. Louis, co-author of the study, remarked, “The trial showed very high rates of re­sponse when elotuzumab is given in com­bi­na­tion with Revlimid.”

Elotuzumab is a new drug that is cur­rently being in­ves­ti­gated as a po­ten­tial treat­ment for mul­ti­ple myeloma. It targets pro­teins that are on the surface of myeloma cells, but not healthy cells. When the drug identifies a can­cer­ous cell, it triggers the cell’s death.

The goal of this study was to de­ter­mine max­i­mum tol­er­ated dose of elotuzumab in com­bi­na­tion with Revlmid and low-dose dexa­meth­a­sone in patients with re­lapsed mul­ti­ple myeloma. Re­searchers also examined the ef­fi­cacy and toxicity of the drug in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Patients en­rolled in this clin­i­cal trial took three dif­fer­en­t doses (5 mg/kg, 10 mg/kg or 20mg/kg) of elotuzumab in com­bi­na­tion with 25 mg of Revlimid, given on days 1-21 in a 28-day cycle, and 40 mg of low-dose dexa­meth­a­sone, given once weekly.

Researchers observed at least a partial re­sponse in 92 per­cent of the patients who had com­pleted at least two treat­ment cycles. This means that the drug removed at least half of the patients’ ab­nor­mal pro­teins and any tumors shrunk by at least 50 per­cent.

They did not observe any dose-limiting toxicities, and the max­i­mum tol­er­ated dose was not estab­lished.

Common side effects asso­ci­ated with this drug in­cluded neu­tro­penia (low num­ber of white blood cells), thrombo­cyto­penia (low num­ber of platelets), fever, and chills.

“Currently a ran­dom­ized Phase 2 extension trial is going to look at two dif­fer­en­t dose levels to see if [the drug] is as ef­fec­tive at a lower dose,” Vij added. “[This year], the plan is to do a multinational Phase 3 trial.”

The study’s authors were op­ti­mis­tic about the ef­fi­cacy of the drug and en­cour­aged by what they called “manageable” side effects.

For more in­for­ma­tion, please see abstract 432 on the ASH meeting Web site.