Elranatamab Post Cilta-cel in Patients With Clinical High... | NCT06947083 | Trialant
NCT06947083
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
Recruiting
Last Update Posted
Dec 3, 2025Actual
Enrollment
39Estimated
Phase
Phase 2
Conditions
Myeloma
Interventions
Elranatamab
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT06947083
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MCC-23564
Secondary IDs
Not provided
Brief Title
Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
Official Title
Phase II Study of Elranatamab as Maintenance Therapy Post Ciltacabtagene-autoleucel(Cilta-cel) in Patients With Clinical High Risk Relapsed Myeloma
Acronym
Not provided
Organization
H. Lee Moffitt Cancer Center and Research InstituteOTHER
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
May 27, 2025Actual
Primary Completion Date
Apr 2029Estimated
Completion Date
Apr 2029Estimated
First Submitted Date
Apr 21, 2025
First Submission Date that Met QC Criteria
Apr 21, 2025
First Posted Date
Apr 27, 2025Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 2, 2025
Last Update Posted Date
Dec 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
H. Lee Moffitt Cancer Center and Research InstituteOTHER
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Myeloma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
39Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Elranatamab Maintenance Therapy
Experimental
Patients who have received cilta-cel without evidence of disease progression and have clinical high-risk myeloma, will be treated with Elranatamab as maintenance therapy for a total of 12 months starting 3-6 months post cilta-cel infusion, at the FDA approved full dose.
Drug: Elranatamab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Elranatamab
Drug
Maintenance therapy
Elranatamab Maintenance Therapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression Free Surival (PFS)
Progression-free survival (PFS) is measured from the date of initiation of Elranatamab (i.e., on-treatment date) to either the date of death from any cause or the date of disease progression, whichever comes first.
Up to 24 Months
Secondary Outcomes
Measure
Description
Time Frame
Complete Response
Proportion of participants with a complete response at the end of treatment.
Up to 12 months
MRD Negative
Proportion of participants with MRD negativity at the end of treatment.
Other Outcomes
Not provided
Eligibility Module
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 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.