Comparison between Eloquent-3 data (arm EloPd) with real-life data

Lead Investigator: Massimo Gentile, Azienda Ospedaliera Di Cosenza
Title of Proposal Research: Comparison between Eloquent-3 data (arm EloPd) with real-life data
Vivli Data Request: 9770
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Multiple myeloma (MM), (also called plasma cell myeloma, or myeloma) is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Globally, about 175,000 people were diagnosed with the disease in 2020, while about 117,000 people died from the disease that year. In the U.S., forecasts suggest about 35,000 people will be diagnosed with the disease in 2023, and about 12,000 people will die from the disease that year.

Elotuzumab is a type of medication used to treat MM, which targets a specific protein on the surface of cancer cells, called SLAMF7. By binding to SLAMF7, elotuzumab helps the immune system recognize and attack the cancer cells more effectively. Elotuzumab also enhances the killing of myeloma cells through two processes that involve immune cells (NK cells and macrophages) being guided and empowered by antibodies to target and eliminate harmful cells or particles in the body – these two processes are called NK cell-powered antibody-dependent cellular cytotoxicity (ADCC) and macrophage-powered antibody-dependent cellular phagocytosis (ADCP).

Elotuzumab works well with other drugs like lenalidomide, pomalidomide, or bortezomib in nonclinical studies. Pomalidomide is a medication that directly kills myeloma cells, affects the immune system, and stops the support from surrounding cells that helps myeloma grow. Specifically, it prevents the growth and prompts the death of certain blood cancer cells, works against cells that are resistant to another drug called lenalidomide, and boosts immune response from certain cells in the body. It works by attaching to a protein called cereblon, which is part of a complex involved in regulating other proteins. By doing this, pomalidomide affects various cellular processes.

In the ELOQUENT-3 trial, combining pomalidomide with elotuzumab and dexamethasone showed significant improvement in the time before the disease progresses compared to using only pomalidomide and dexamethasone. This trial involved patients with relapsed or refractory multiple myeloma who had already been treated with lenalidomide and a proteasome inhibitor.

High-risk multiple myeloma (MM) is when abnormal plasma cells have certain genetic abnormalities, like specific chromosomal changes or mutations. Renal impairment is a condition where the kidneys can’t effectively remove waste from the blood, functioning at less than 15% of normal. In multiple myeloma, kidney failure often occurs because of proteins released by the cancer cells. Relapsed-refractory multiple myeloma (RRMM) refers to a condition which is resistant to formerly effective treatment.
The necessity of the research is the lack of comparison between RRMM patients enrolled in registered study Eloquent-3 (sperimental arm) and RRMM patients treated with Elotuzumab-Pomalidomide-Dexamethasone outside clinical trial. We recently reported on a real-world experience involving 200 RRMM patients from 35 Italian hematological centers who were treated with Elotuzumab plus Pomalidomide in a recently published study.

Requested Studies:

An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) ID NCT02654132
Data Contributor: Bristol Myers Squibb
Study ID: NCT02654132
Sponsor ID: NCT02654132