New Vaccine-Drug combo takes on Hard-to-Treat myeloma
NCT ID NCT06799026
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether combining a personalized cancer vaccine (made from a patient's own tumor and immune cells) with the drug elranatamab is safe and feasible for people with multiple myeloma that has returned or stopped responding to prior treatments. Up to 25 participants will receive the vaccine along with elranatamab and a growth factor. The main goals are to see if the vaccine can be made successfully and to monitor for serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dendritic cell/myeloma fusion vaccine plus elranatamab
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with multiple myeloma that has stopped responding to standard therapies.
- What could go wrong
- This is a very early phase 1 trial with only 25 participants, so the main goals are safety and feasibility. It is too soon to know if the combination will be effective, and there are risks of serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Tumor Collection: * 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. Exclusion Criteria for Tumor Collection: * 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 * Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary. * 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 * ECOG performance status ≤ 2 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 * ANC \> 1K/uL; Platelets \> 50 K/uL without transfusional support * Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas