No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
39 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for
This trial is looking for patients with high risk relapsed myeloma who have recently received cilta-cel treatment. Participants will receive Elranatamab to see how well it helps prevent their myeloma from progressing.
Are You a Good Fit for This Trial?
Rules you outActive plasma cell leukemiaOngoing active infectionCNS involvementGuillain-Barre syndromeRenal failure requiring dialysis
You may be able to join if
I understand and can sign the consent form.
I have received cilta-cel for my relapsed myeloma in the last 3-6 months.
I have had more than 2 previous treatments for my condition.
I can follow the study visit schedule.
I have a clonoseq ID available before enrolling.
My Eastern Cooperative Group (ECOG) Performance Status is 0 or 1.
My bilirubin levels are within the normal range.
My bone marrow function is adequate.
You may not be able to join if
I have an ongoing active infection requiring IV antibiotics.
I currently have ongoing CRS or ICANS.
I have active plasma cell leukemia.
I have cancer in my brain or meninges.
I have a history of Guillain-Barre syndrome.
I have uncontrolled medical problems like diabetes or heart disease.
I am pregnant or breastfeeding.
I have renal failure requiring dialysis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in …
The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma and have high risk cytogenetics by IMW (del17p, or t(4;14) or t(14;16) or history of EMD, and must not have evidence of progressive …
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma and have high risk cytogenetics by IMW (del17p, or t(4;14) or t(14;16) or history of EMD, and must not have evidence of progressive disease by IMWG criteria(Appendix B) following CAR-T cell therapy.
* Have received \>2 prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor and a CD38 monoclonal antibody.
* Able to adhere to the study visit schedule and other protocol requirements.
* Patients must have available clonoseq ID prior to enrollment to track MRD status.
* Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
* Serum bilirubin levels ≤1.5 times the upper limit of the normal range for the laboratory (ULN), unless related to Gilbert syndrome.
* Serum AST or serum ALT levels ≤2 x ULN.
* Must have adequate bone marrow function.
Exclusion Criteria:
* Ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment.
* Ongoing CRS or ICANS of any grade.
* Active plasma cell leukemia.
* Patients with CNS involvement, including meningeal involvement.
* Patients with history of Guillain-Barre syndrome.
* Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma, which in the opinion of the treating physician pose an unacceptable risk to the patient.
* Pregnant or lactating females.
* Concurrent use of other anti-cancer agents or treatments.
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Note: patients with hepatitis C previously treated with curative intent are considered eligible.
* Patients with renal failure requiring dialysis.
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