This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).
The names of the study drugs and vaccine involved in this study are:
* DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) * Elranatamab (a type of T-cell engager antibody)
Participants must have an established diagnosis of multiple myeloma
Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy
Participants must have at least 3 prior lines of therapy
Participants must be ≥18 years of age
Patients who are receiving any other investigational agents.
Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
Patients with Plasma Cell Leukemia
Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
Single group
Elranatamab
DrugBispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
GM-CSF
Biological/VaccineGranulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
DC/MM Fusion Vaccine
Biological/VaccineDendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.
Administration of DC/MM Vaccine
Feasibility is defined as number of patients who successfully get vaccine
Grade 3-4 Non-hematologic Rate
Grade 3-4 non-hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 non-hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Grade 3-4 hematologic Rate
Grade 3-4 hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Median Overall Survival (OS)
Overall survival based on the Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
Median Progression Free Survival (PFS)
PFS based on Kaplan Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation.
Elranatamab Toxicity Rate
Elranatamab Toxicity Rate is defined as percentage of participants who experienced elranatamab toxicity including cytokine release syndrome, neurotoxicity and infections based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
MRD Negative Disease Rate at 1 Year
MRD Negative Disease Rate at 1 Year is defined as the percentage of participants who are MR- negative after 1 year.
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