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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment combination can safely and effectively treat Relapsed or Refractory Multiple Myeloma, a type of blood cancer that returns after standard treatments or doesn't respond to them. The treatment combines a personalized cancer vaccine made from the patient’s own cells (DC/MM Fusion Vaccine) with a drug called elranatamab, which helps the immune system attack cancer cells. People with multiple myeloma who experience frequent relapses after at least three different treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the DC/MM fusion vaccine was generally well tolerated by patients with multiple myeloma, with most not reporting any serious side effects. The vaccine has triggered immune responses against the cancer and helped stabilize the disease in many patients.

Research indicates that elranatamab is also well tolerated by patients with relapsed or refractory multiple myeloma. Some patients experienced more severe side effects, but these were manageable, especially with adjusted dosing schedules. Recent studies have not identified any new safety concerns.

Overall, both the DC/MM fusion vaccine and elranatamab have been tested and found to be generally safe for patients with multiple myeloma, with manageable side effects. For those considering joining a trial with these treatments, this evidence suggests they are relatively safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the DC/MM Fusion Vaccine and Elranatamab combination because it offers a novel approach to treating multiple myeloma. Unlike standard treatments such as chemotherapy, targeted therapies, or immunomodulatory drugs, Elranatamab works by specifically targeting and engaging T-cells to attack cancer cells. The DC/MM Fusion Vaccine is designed to enhance the immune response by training the immune system to recognize and fight the myeloma cells more effectively. This combination seeks to harness the body's own defenses in a more precise manner, potentially leading to better outcomes for patients with fewer side effects.

What evidence suggests that the DC/MM fusion vaccine and elranatamab combination might be effective for multiple myeloma?

In this trial, participants will receive a combination of the DC/MM fusion vaccine and elranatamab to treat relapsed or refractory multiple myeloma. Studies have shown promising results for this combination, which enhances the body's immune response. The DC/MM fusion vaccine merges the patient's cancer cells with dendritic cells, helping the immune system better identify and fight the cancer. Elranatamab, an antibody, activates T-cells, crucial immune cells, to attack cancer cells. Previous research showed that patients receiving similar treatments responded well, with many experiencing significant improvements. Overall, these treatments have shown potential in improving outcomes for patients with this challenging condition. ^{1 4 6 7 8}

Who Is on the Research Team?

David Avigan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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

Patients with uncontrolled intercurrent illness

I have been diagnosed with Plasma Cell Leukemia.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06799026

NCT06799026 | A Phase 1 Study of Vaccination With ... 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 ...

2. myeloma.org myeloma.org/sparkcures/trial/2056

Dendritic Cell / Multiple Myeloma Fusion Vaccine ... (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the ...

3. sparkcures.com sparkcures.com/treatment/302/elranatamab

Elranatamab Myeloma Trials The median overall survival (OS) was 10.1 months (95% CI, 6.79-13), and the 1-year OS rate was 41.9% (95% CI, 31.7%-52.1%).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690096/

Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion ... Best response of VGPR or better at 1 year was achieved by 85.3% and 77.8% of patients on the vaccine and nonvaccine arms, respectively (P = 0.2). A secondary ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00899

A Vaccine (DC/MM Fusion) in Combination with ... Giving the DC/MM fusion vaccine in combination with elranatamab may be safe, tolerable and/or effective in treating patients with relapsed or refractory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3031474/

Vaccination with dendritic cell/tumor fusion cells results in ... Vaccination with DC/multiple myeloma fusions was feasible and well tolerated and resulted in antitumor immune responses and disease stabilization in a majority ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03782064/

Clinical Trial: NCT03782064 This research study is studying a cancer vaccine called Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) in combination with nivolumab, ...

8. withpower.com withpower.com/trial/dcmm-fusion-vaccine-elranatamab-for-multiple-myeloma-591e2

DC/MM Fusion Vaccine + Elranatamab for Multiple Myeloma 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 ...