ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma

Description

The ELDORADO trial is a phase 2, randomized, open label, multicenter study that will enroll approximately 160 patients (10 patient safety run and 150 patients for randomization) to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the standard combination of daratumumab and hyaluronidase, lenalidomide, bortezomib, dexamethasone in newly diagnosed, transplant ineligible/deferred multiple myeloma patients. Pfizer, Inc. is supporting this research by providing the study drug, elranatamab, and funding for research activities. Patients will receive treatment for 24 cycles. For patients who meet certain testing parameters, some patients may be able to discontinue treatment and be observed. Other patients may continue with the treatment that they have been receiving until disease progression. Patients may discontinue treatment if they experience unacceptable adverse events, their condition changes rendering them unacceptable for further treatment, they experience intercurrent illness that prevents further administration of treatment, they demonstrate an inability or unwillingness to comply with the medication regimen and/or documentation requirements, or they withdraw from the study. Patients will be followed for a period of 5 years from when the last participant discontinues treatment. The majority of this follow up will not be in person and will be through review of the patients’ charts. The U.S. FDA has not approved the combination of elranatamab or daratumumab with lenalidomide, bortezomib, and dexamethasone (elra-RVd lite or dara-RVd lite) as a treatment for any disease. Elranatamab is a bispecific antibody, meaning it can attach to two different things at the same time. Elranatamab, specifically, connects to cancer cells, as well as to a certain type of immune cells, called T cells, to help the immune system attack and destroy the cancer cells. Daratumumab recognizes and attaches to a protein found on the surface of cancer cells, called CD38. This aids the immune system in identifying and destroying cancer cells. Lenalidomide is an immunomodulatory drug. Immunomodulatory drugs help control or adjust how the immune system works, whether it is too weak or too aggressive to more effectively fight infections and cancers. Bortezomib is a proteasome inhibitor, meaning it blocks proteasome in cells. Proteasome aids in cell growth and development. When proteasome is blocked, damaged proteins build up, stressing a cancer cell, and eventually cause cell death. Dexamethasone is a glucocorticoid (a substance that stops inflammation caused by immune system disorders) that has shown significant activity in myeloma. It is believed to aid in anti-myeloma effects, which may lead to the destruction of myeloma cancer cells.