A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
1 other identifier
interventional
25
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Jan 2025
Typical duration for phase_1 multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedStudy Start
First participant enrolled
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
May 7, 2026
May 1, 2026
3.6 years
January 23, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Administration of DC/MM Vaccine
Feasibility is defined as number of patients who successfully get vaccine
1 Year
Grade 3-4 Non-hematologic Rate
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.
1 Year
Grade 3-4 hematologic Rate
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.
1 Year
Secondary Outcomes (4)
Median Overall Survival (OS)
18 months
Median Progression Free Survival (PFS)
1 Year
Elranatamab Toxicity Rate
1 Year
MRD Negative Disease Rate at 1 Year
1 Year
Study Arms (1)
Elranatamab + DC/MM Vaccine + GM-CSF
EXPERIMENTAL* 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
Interventions
Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.
Eligibility Criteria
You may qualify if:
- Participants must have an established diagnosis of multiple myeloma
- Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy
- Participants must have at least 3 prior lines of therapy
- Participants must be ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Participants must have \> 20% plasma cells in the bone marrow core or aspirate differential \<30 days prior to enrollment.
- ANC \> 1K/uL; Platelets \> 50 K/uL without transfusional support
- Participants must have adequate organ function as defined below:
- Total bilirubin ≤1.5 x institutional upper limit of normal
- AST ≤ 3 x institutional upper limit of normal
- ALT ≤ 3 x institutional upper limit of normal
- Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
- The effects of DC/MM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.
- Ability to understand and willingness to sign a written informed consent document.
You may not qualify if:
- Patients who are receiving any other investigational agents.
- Patients with purely non-secretory MM \[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \>100 mg/L\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- Patients with Plasma Cell Leukemia
- Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
- Active and clinically significant autoimmune or inflammatory disorder requiring active treatment
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
- Female patients who are pregnant (positive β-HCG) or breastfeeding
- Prior organ transplant requiring immunosuppressive therapy.
- Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Eligibility Criteria Prior to Vaccination with DC/MM fusions
- Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine
- Absence of disease progression following 2 cycles of elranatamab therapy
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Aviganlead
- Pfizercollaborator
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Avigan, MD
Beth Israel Deaconess Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
January 23, 2025
First Posted
January 29, 2025
Study Start
January 31, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2030
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.