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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Avigan

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Elranatamab
  • GM-CSF
  • DC/MM Fusion Vaccine

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

David Avigan

Lead sponsor

Beth Israel Deaconess Medical Center

Sponsor institution

Pfizer

Collaborator