Phase 1 Study of Personalized Dendritic Cell and Multiple Myeloma Fusion Vaccine Combined With Elranatamab for Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and effects of combining a personalized cancer vaccine made from participants own tumor and immune cells DCMM fusion vaccine with the drug elranatamab in adults with relapsed or refractory multiple myeloma. This phase 1 study aims to understand how well this combination works and its impact on the immune system in treating this type of cancer, which has returned or not responded to previous treatments. Participants will receive subcutaneous injections of elranatamab daily according to a defined schedule over 12 cycles lasting 28 days each. The DCMM fusion vaccine and a growth factor called GM-CSF will also be given during certain cycles to potentially boost the immune response. Bone marrow biopsies and various imaging scans will be performed at specific times throughout the study to monitor the disease and treatment effects. After completing treatment, participants will have follow-up visits for up to five years. Throughout the study, participants will undergo multiple assessments including blood and urine tests, CT, MRI, or PET scans, and bone marrow collections. Researchers will monitor safety by tracking side effects such as serious blood-related or non-blood-related issues over one year. They will also measure outcomes like overall survival, disease progression, and the presence of minimal residual disease. The study includes up to 25 participants and is funded by Pfizer, which provides elranatamab for the trial.

A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma