Clinical Studies - Multiple Myeloma Research Foundation

MULTIPLE MYELOMA KNOWLEDGE CENTER

What have Empliciti clinical trials shown?

The safety and efficacy of Empliciti™ (elotuzumab, Bristol-Myers Squibb/AbbVie) has been demonstrated in several clinical trials in patients with relapsed and/or refractory multiple myeloma.

The combination of Empliciti plus Revlimid® (lenalidomide, Celgene) and low-dose dexamethasone (Revlimid-low-dose dex, or Rd) was compared to Rd alone in a Phase III trial known as ELOQUENT-2, which supported the approval of Empliciti. This trial included 646 patients who had received one to three prior therapies and had progressed following their most recent therapy.

  • The addition of Empliciti to Rd resulted in a 30% reduction in risk of disease progression or death compared to Rd alone.
  • On average, the time that patients receiving Empliciti-Rd lived without their disease worsening was 19.4 months compared with 14.9 months with Rd.
  • This significant progression-free survival benefit with Empliciti-Rd was maintained over time, with higher rates compared with Rd at one year (68% vs. 57%), two years (41% vs. 27%), and three years (26% vs. 18%).
  • In addition, a significantly higher percentage of patients taking Empliciti with Rd achieved a partial response or better compared to those only taking Rd (overall response rate of 79% vs. 66%).
  • Based on these results, Empliciti-Rd is listed as one of several preferred regimens for previously treated myeloma in recent treatment guidelines.

Empliciti has also been evaluated as part of combination therapy in Phase II clinical trials that were facilitated by the Multiple Myeloma Research Consortium (MMRC).

  • For example, a trial of Empliciti plus Revlimid-dex in 73 patients who had received an average of three prior therapies reported an overall response rate of 84% and found that the 10 mg/kg dose of Empliciti was more effective than a 20 mg/kg dose.

How is Empliciti currently being studied in myeloma?

In addition to the ELOQUENT-2 trial, a second Phase III trial (ELOQUENT-1) is evaluating whether adding Empliciti to Rd as treatment for newly diagnosed myeloma will increase the length of time before the disease progresses. A substudy will determine if patients receiving added Empliciti have lower levels of the SLAMF7/CS1 marker on their myeloma cells at time of disease progression. Both trials are fully enrolled.

Additional trials are being conducted in a variety of settings, including newly diagnosed myeloma, relapsed/refractory disease, and smoldering multiple myeloma., and use as maintenance therapy following stem cell transplant.

Interested in learning more about Empliciti clinical trials? Talk to an MMRF Patient Support Nurse to learn more or use our clinical trials finder:

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