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)
This is a phase 1 study to evaluate the feasibility, safety, clinical and immune effects of DC/MM fusion vaccine in combination with Elranatamab in participants with relapsed/refractory multiple myeloma. The DC/MM fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. This vaccine is individualized for each participant using dendritic cells (type of immune cells) from each participant. GM-CSF contains a substance that helps make more white blood cells. This medication is being used to possibly increase the effectiveness of the DC/MM fusion vaccine. The U.S. Food and Drug Administration (FDA) has not approved DC/MM fusion vaccine as a treatment for Relapsed or Refractory Multiple Myeloma. The FDA has not approved GM-CSF as a treatment for Relapsed or Refractory Multiple Myeloma. The FDA has approved elranatamab as a treatment option for Relapsed or Refractory Multiple Myeloma. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, study drug subcutaneous (under the skin) injections, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and bone marrow biopsies and aspirations (or collections). Participants will receive study treatment for up to 12 cycles (28-day cycles) and will be followed for up to 5 years. It is expected that about 25 people will take part in this research study. Pfizer is funding this research study by providing one of the study drugs, Elranatamab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
NOT_YET_RECRUITINGAdministration of DC/MM Vaccine
Feasibility is defined as number of patients who successfully get vaccine
Time frame: 1 Year
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.
Time frame: 1 Year
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.
Time frame: 1 Year
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.
Time frame: 18 months
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.
Time frame: 1 Year
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.
Time frame: 1 Year
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.
Time frame: 1 Year
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