Actively Recruiting
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusion Vaccine Combined With Elranatamab in Relapsed or Refractory Multiple Myeloma
Led by David Avigan · Updated on 2026-05-07
25
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
D
David Avigan
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of combining a personalized cancer vaccine made from participants' own tumor and immune cells (DC/MM fusion vaccine) with the drug elranatamab in adults with relapsed or refractory multiple myeloma. This phase 1 study aims to understand how well this combination works and its impact on the immune system in treating this type of cancer, which has returned or not responded to previous treatments. Participants will receive subcutaneous injections of elranatamab daily according to a defined schedule over 12 cycles lasting 28 days each. The DC/MM fusion vaccine and a growth factor called GM-CSF will also be given during certain cycles to potentially boost the immune response. Bone marrow biopsies and various imaging scans will be performed at specific times throughout the study to monitor the disease and treatment effects. After completing treatment, participants will have follow-up visits for up to five years. Throughout the study, participants will undergo multiple assessments including blood and urine tests, CT, MRI, or PET scans, and bone marrow collections. Researchers will monitor safety by tracking side effects such as serious blood-related or non-blood-related issues over one year. They will also measure outcomes like overall survival, disease progression, and the presence of minimal residual disease. The study includes up to 25 participants and is funded by Pfizer, which provides elranatamab for the trial.
CONDITIONS
Brief Title
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have an established diagnosis of multiple myeloma
- Must have relapsed or refractory multiple myeloma after treatment with proteasome inhibitors, IMiDs, and anti-CD38 monoclonal antibody therapy
- Must have had at least 3 prior lines of therapy
- Must be 18 years of age or older
- ECOG performance status of 2 or less
- More than 20% plasma cells in bone marrow core or aspirate within 30 days before enrollment
- Absolute neutrophil count (ANC) above 1,000/uL; platelets above 50,000/uL without transfusion support
- Adequate organ function including total bilirubin 1.5 times or less the upper normal limit, AST and ALT 3 times or less the upper normal limit, and creatinine clearance of 40 mL/min or higher if creatinine is elevated
- Women and men of child-bearing potential must agree to use effective contraception during and for 6 months after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving other investigational agents
- Having non-secretory multiple myeloma without detectable monoclonal protein or Bence-Jones protein; light chain multiple myeloma detected by free light chain assay is allowed
- Diagnosis of plasma cell leukemia
- Known HIV infection or active hepatitis B or C infection
- Recent heart attack within 6 months or severe heart failure or other serious heart conditions
- Active autoimmune or inflammatory disorders requiring treatment
- History of other cancers unless disease-free for at least 2 years or specific skin cancers treated within 5 years
- Pregnant or breastfeeding women
- Prior organ transplant needing immunosuppressive therapy
- Previous PD-1 antibody treatment causing treatment stop due to toxicity
- Uncontrolled illnesses including infections, heart conditions, or psychiatric issues that limit study compliance
- History of Guillain-Barré syndrome or serious peripheral motor neuropathy
- Unresolved severe toxicities from prior elranatamab treatment
- Disease progression after 2 cycles of elranatamab before vaccination
- Failure to produce at least 2 vaccines with required fusion cells
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive Elranatamab injections and DC/MM fusion vaccine combined with GM-CSF injections as part of their treatment.
Multiple visits for study drug injections and assessments during each 28-day cycle
Duration - Up to 5 years
Participants have bone marrow biopsies and other assessments after treatment ends to monitor recovery and long-term effects.
Visits at months 1, 3, 6 after treatment and long-term follow-up visits up to 5 years
Trial Site Locations
Total: 2 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
D
David Avigan, MD
E
Emma Logan, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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