DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I study combines a personalized dendritic cell/tumor (DC/MM) fusion vaccine and GM‑CSF with standard-of-care BCMA-directed CAR‑T therapy in adults with relapsed or refractory multiple myeloma. Participants undergo leukapheresis to collect cells for vaccine manufacture, receive CAR‑T infusion per standard practice, and receive vaccine doses with serial blood tests, imaging, and bone marrow biopsies for monitoring. The trial is designed to characterize safety and look for early signs of added effectiveness in about 25 participants. The DC/MM fusion vaccine is investigational and not FDA-approved for this indication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma
* Patients must be ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment.
* Patients 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:

* Patients receiving other investigational drugs
* Patients with Plasma Cell Leukemia

  * Patients who have known active uncontrolled infections with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
  * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
* Female patients who are pregnant (positive β-HCG) or breastfeeding.
* Prior organ transplant requiring immunosuppressive therapy.
* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of intolerance to CAR-T related drugs or GM-CSF.

Inclusion Criteria Prior to Vaccination with DC/MM Fusions:

* Resolution of all CAR T- related grade 3-4 toxicities
* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells
* Absence of disease progression following CAR T-cell therapy
* ECOG performance status ≤ 2
* Patients 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 within normal limits or Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
  * ANC \>1000 in the absence of growth factor support in the prior 7 days
  * Platelet count \>50K without the need for transfusion in the prior 7 days
  * No myeloma-directed therapy following administration of CAR T-cells

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jacalyn Rosenblatt, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Jacalyn Rosenblatt, MD
• Email: jrosenb1@bidmc.harvard.edu
• Phone: 617-667-9920

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FT836 CAR T-cell Therapy with Daratumumab in relapsed/refractory multiple myeloma

  This phase 1 study tests whether FT836 CAR T cells given with daratumumab are safe and show early signs of activity in adults with relapsed or refractory multiple myeloma who have had at least three prior therapies.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT07221032

• Personalized dendritic cell–myeloma fusion vaccine combined with elranatamab for relapsed or refractory multiple myeloma

  This will try a personalized dendritic cell–myeloma fusion vaccine given with elranatamab in people with relapsed or refractory multiple myeloma.

  Recruiting at 2 sites Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts and 1 other locations · NCT06799026

• Using elranatamab to treat relapsed/refractory multiple myeloma

  This study is testing if a new drug called elranatamab can help people with tough-to-treat multiple myeloma feel better and keep their disease from getting worse.

  Recruiting at 3 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT06138275

• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

  A one-arm phase 1 study tests a new BCMA-TGFβ CAR-T cell therapy to see if it is safe and provides signs of benefit in adults whose multiple myeloma has come back or persisted after prior treatments.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05976555

• CAR-T therapy targeting BCMA for multiple myeloma patients

  This study is testing a new CAR-T therapy for people with tough-to-treat multiple myeloma to see if it is safe and effective.

  Recruiting Phase 1/2 Sheba Medical Center · Ramat Gan · NCT05243212

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

  This project will see how CAR‑T therapy affects older adults (age 60+) with relapsed or refractory B‑cell lymphomas, focusing on daily function and quality of life while they receive standard care.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT04300998

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.