A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple MyelomaRelapse Multiple MyelomaRefractory Multiple Myeloma
- Interventions
- Registration Number
- NCT06799026
- Lead Sponsor
- David Avigan
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elranatamab + DC/MM Vaccine + GM-CSF Elranatamab * Baseline visit and assessments * Leukapheresis * Cycle 1 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 2 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycles 3 through 5 (28-day cycles): * Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered) * Cycle 6 (28-day cycle): * Bone marrow biopsy/aspiration on Cycles 6, 9, and 12 * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 7 through 12 (28-day cycles): * Cycle 7 Day 1 only: Bone marrow biopsy/aspiration * Days 1 and 15: Predetermined dose of Elranatamab 1x daily * After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6 * 6 month follow up visit * Long term follow up 5 years Elranatamab + DC/MM Vaccine + GM-CSF GM-CSF * Baseline visit and assessments * Leukapheresis * Cycle 1 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 2 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycles 3 through 5 (28-day cycles): * Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered) * Cycle 6 (28-day cycle): * Bone marrow biopsy/aspiration on Cycles 6, 9, and 12 * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 7 through 12 (28-day cycles): * Cycle 7 Day 1 only: Bone marrow biopsy/aspiration * Days 1 and 15: Predetermined dose of Elranatamab 1x daily * After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6 * 6 month follow up visit * Long term follow up 5 years Elranatamab + DC/MM Vaccine + GM-CSF DC/MM Fusion Vaccine * Baseline visit and assessments * Leukapheresis * Cycle 1 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 2 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycles 3 through 5 (28-day cycles): * Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered) * Cycle 6 (28-day cycle): * Bone marrow biopsy/aspiration on Cycles 6, 9, and 12 * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 7 through 12 (28-day cycles): * Cycle 7 Day 1 only: Bone marrow biopsy/aspiration * Days 1 and 15: Predetermined dose of Elranatamab 1x daily * After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6 * 6 month follow up visit * Long term follow up 5 years
- Primary Outcome Measures
Name Time Method Administration of DC/MM Vaccine 1 Year Feasibility is defined as number of patients who successfully get vaccine
Grade 3-4 Non-hematologic Rate 1 Year 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 1 Year 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.
- Secondary Outcome Measures
Name Time Method Median Overall Survival (OS) 18 months 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) 1 Year 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 1 Year 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 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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Trial Locations
- Locations (2)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States