Actively Recruiting
A Phase 2 Study of Elranatamab as Consolidation After Idecabtagene Vicleucel in Relapsed Refractory Multiple Myeloma
Led by Massachusetts General Hospital · Updated on 2026-03-13
32
Participants Needed
3
Research Sites
121 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating elranatamab, a type of antibody drug, to see if it can reduce the risk of disease worsening after treatment with idecabtagene vicleucel in adults with relapsed and refractory multiple myeloma who have already undergone four or more prior treatments. This open-label phase II study involves patients who have received idecabtagene vicleucel as standard care and achieved at least a partial response. Participants will receive elranatamab through subcutaneous injections given on specific days within 28-day cycles: during Cycle 1 on Days 1, 4, 8, 15, and 22; Cycle 2 on Days 1, 8, 15, and 22; and Cycles 3 to 6 on Days 1 and 15. Treatment may continue for up to six months or until disease progression or start of another myeloma therapy. During the study, participants will attend regular visits for assessments including disease evaluations and safety monitoring. Researchers will measure outcomes such as complete response rates, progression-free survival, adverse events, overall survival, and minimal residual disease status over multiple years. Participants will be followed as long as they remain in the study or until disease progression or other myeloma treatments begin, with evaluations planned up to five years.
CONDITIONS
Brief Title
Elranatamab in R/R Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has given voluntary signed written informed consent before any study procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Male or female participants aged 18 years or older.
- Agree to use adequate contraception during the study if of child-bearing potential.
- Prior diagnosis of multiple myeloma according to IMWG criteria.
- Measurable multiple myeloma disease prior to idecabtagene vicleucel treatment.
- Previously treated relapsed and refractory multiple myeloma after idecabtagene vicleucel with at least partial response.
- Left ventricular ejection fraction of 40% or higher.
- Adequate organ and marrow function as defined by specific blood counts and liver/kidney tests.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Patients with smoldering multiple myeloma, plasma cell leukemia, POEMS syndrome, or amyloidosis.
- Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease.
- Active hepatitis B or C, SARS-CoV2, HIV, or uncontrolled infections.
- Significant cardiovascular diseases or events within 6 months prior to enrollment.
- Any other active malignancy within 3 years except certain skin cancers.
- Ongoing grade 2 or higher peripheral neuropathy or history of Guillain-Barré syndrome.
- Previous treatment with an anti-BCMA bispecific antibody.
- Pregnant or breastfeeding women.
- Known allergy to the study drug or its components.
- Use of other investigational agents for multiple myeloma.
- Live attenuated vaccine within 4 weeks before study drug.
- Unresolved toxicity from prior anticancer therapy except alopecia and peripheral neuropathy.
- Other medical, surgical, or psychiatric conditions that increase risk or interfere with participation.
- Investigational drug use within 30 days or 5 half-lives prior to study drug administration if applicable.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive subcutaneous injections of elranatamab during 28-day cycles for up to 6 months.
Multiple visits over 6 cycles with injections on specified days within each 28-day cycle
Duration - Up to several years depending on disease progression
Participants are followed for disease progression, survival, and safety after treatment ends until disease worsening, start of other myeloma treatment, or study end.
Visits as scheduled for ongoing disease evaluation and safety monitoring
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
N
Noopur Raje, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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