DC/MM Fusion Vaccine + Elranatamab for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Emma Logan, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: David Avigan

Must not be taking: Investigational agents

Disqualifiers: HIV, Hepatitis B/C, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents.

What data supports the effectiveness of the DC/MM Fusion Vaccine + Elranatamab treatment for Multiple Myeloma?

Research shows that a similar vaccine, the dendritic cell/myeloma fusion vaccine, can trigger immune responses against multiple myeloma and help stabilize the disease in many patients. This suggests that the DC/MM Fusion Vaccine might also be effective in treating multiple myeloma by boosting the body's immune response to the cancer. ^{1 2 3 4 5}

Is the DC/MM Fusion Vaccine safe for humans?

The DC/MM Fusion Vaccine has been tested in patients with multiple myeloma and was generally well tolerated, with no serious side effects reported in a phase 1 study. It resulted in immune responses and disease stabilization in many patients. ^{2 3 4 5 6}

How is the DC/MM Fusion Vaccine + Elranatamab treatment different from other treatments for multiple myeloma?

The DC/MM Fusion Vaccine + Elranatamab treatment is unique because it combines a vaccine made from a patient's own myeloma cells and dendritic cells (immune cells that help trigger an immune response) with Elranatamab, aiming to stimulate a strong immune response against the cancer. This approach is different from standard treatments as it focuses on personalized immunotherapy, potentially offering a more targeted and less toxic option. ^{2 3 4 5 7}

What is the purpose of 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)

Research Team

David Avigan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for individuals with Multiple Myeloma that has returned or hasn't responded to treatment. Participants must have measurable levels of myeloma proteins, adequate organ function, and no other active cancers. They should not be pregnant and must agree to follow specific contraceptive guidelines.

Inclusion Criteria

ANC > 1K/uL; Platelets > 50 K/uL without transfusional support

I have been diagnosed with multiple myeloma.

I have undergone at least 3 different treatments.

Exclusion Criteria

I have been diagnosed with Plasma Cell Leukemia.

I have had an organ transplant and am on immunosuppressive drugs.

I have had Guillain-Barre Syndrome or severe nerve damage in my limbs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Elranatamab and DC/MM fusion vaccine over 12 cycles of 28 days each

12 months

Weekly visits during each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Visits at months 1, 3, and 6

Long-term follow-up

Participants are monitored for long-term outcomes and survival

5 years

Treatment Details

Interventions

• DC/MM Fusion Vaccine
• Elranatamab

Trial Overview The study tests a personalized cancer vaccine made from the patient's own cells combined with elranatamab, an antibody designed to engage T-cells in fighting cancer. It aims to see if this combination can safely improve outcomes for those with relapsed or refractory Multiple Myeloma.

Participant Groups

Group I: Elranatamab + DC/MM Vaccine + GM-CSF Experimental Treatment 3 Interventions

* 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

Who Is Running the Clinical Trial?

David Avigan

Lead Sponsor

Trials

1

Recruited

30+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In a study of 44 patients with multiple myeloma, the two-dose SARS-CoV-2 mRNA vaccination showed low rates of adverse reactions, similar to those seen in general vaccine trials.

A high percentage of patients (93% on therapy and 94% not on therapy) developed detectable antibodies after the second dose, indicating strong immunogenicity and providing reassurance for vaccine-hesitant patients with multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. Greenberg, RS., Ruddy, JA., Boyarsky, BJ., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Allogeneic Multiple Myeloma GM-CSF-Secreting Vaccine with Lenalidomide Induces Long-term Immunity and Durable Clinical Responses in Patients in Near Complete Remission. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Personalized Medicine's Coming of Age: One Drug, One Patient. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Vaccination with dendritic cell/tumor fusion cells results in cellular and humoral antitumor immune responses in patients with multiple myeloma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cellular and vaccine immunotherapy for multiple myeloma. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Dendritic cell/myeloma hybrid vaccine. [2005]