Actively Recruiting
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
Led by David Avigan · Updated on 2026-05-07
25
Participants Needed
2
Research Sites
291 weeks
Total Duration
On this page
Sponsors
D
David Avigan
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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
- Participants must have relapsed or refractory multiple myeloma after proteasome inhibitors, IMiDs, and anti-CD38 mAb therapy
- Participants must have had at least 3 prior lines of therapy
- Participants must be 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Participants must have more than 20% plasma cells in bone marrow within 30 days before enrollment
- Absolute neutrophil count (ANC) greater than 1,000/uL and platelets greater than 50,000/uL without transfusions
- Adequate organ function including total bilirubin ≤ 1.5 times upper limit of normal, AST and ALT ≤ 3 times upper limit of normal, and creatinine clearance ≥ 40 mL/min if creatinine is above normal
- Women and men of childbearing potential must agree to use adequate contraception before and during the study, and men for 6 months after treatment ends
- Ability to understand and sign informed consent
- Resolution of grade 3 or higher elranatamab-related toxicities to grade 1 or baseline before vaccination
- Successful production of at least 2 vaccines with minimum 1 x 10^6 fusion cells per vaccine
- No disease progression after 2 cycles of elranatamab therapy
- ECOG performance status ≤ 2 before vaccination
- Adequate organ function before vaccination including bilirubin, AST, ALT, ANC, platelets, and creatinine clearance as above
You will not qualify if you...
- Receiving any other investigational agents
- Having purely non-secretory multiple myeloma (no measurable monoclonal protein or related markers)
- Diagnosis of plasma cell leukemia
- Known infection with HIV, active hepatitis B, or active hepatitis C
- Myocardial infarction within 6 months prior to enrollment or advanced heart failure (NYHA Class III or IV), uncontrolled angina, severe arrhythmias, or acute ischemia
- Active and significant autoimmune or inflammatory disorders requiring treatment
- History of other cancers unless disease-free for at least 2 years or specific non-invasive cancers treated within past 5 years
- Pregnant or breastfeeding female patients
- Prior organ transplant requiring immunosuppressive therapy
- Previous PD-1 antibody treatment causing discontinuation due to toxicity
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- History of Guillain-Barré Syndrome or severe peripheral motor polyneuropathy (Grade 3 or higher)
AI-Screening
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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
CONTACT
E
Emma Logan, MSN
CONTACT
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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