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New treatment option for Multiple Myeloma
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
ClinicalTrials.gov ID: NCT06799026
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as PF-06863135, Elranatamab-bcmm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H)...
See the full eligibility 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...
- Ability to understand and willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.