Actively Recruiting
A Phase 2 Study of Elranatamab in Combination With Isatuximab in Relapsed and Refractory Multiple Myeloma
Led by Massachusetts General Hospital · Updated on 2026-03-12
30
Participants Needed
3
Research Sites
104 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 combined with isatuximab given as injections under the skin for patients with relapsed and refractory multiple myeloma (RRMM) who have had at least two prior treatments including immunomodulatory drugs and proteasome inhibitors. This phase 2, open-label study aims to see if these study drugs reduce disease worsening and to assess their possible risks. Isatuximab is normally given intravenously but will be given subcutaneously using a new delivery device that is being studied. Participants will receive elranatamab injections into the abdomen or lower stomach on specific days in 28-day treatment cycles, with more frequent dosing in the first cycle and less frequent in later cycles. Isatuximab will be given subcutaneously using an investigational on-body delivery system device during certain visits starting from the second cycle. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The first six patients will be closely monitored for safety before enrolling others. During the study, participants will have an initial inpatient stay of 2 to 8 days for close monitoring of the first dose. Follow-up visits will occur every three months for up to five years after treatment ends. Researchers will assess outcomes including the objective response rate, drug-related toxicities, progression-free survival, overall survival, and minimal residual disease status. Regular safety assessments and evaluations will be conducted throughout the study.
CONDITIONS
Brief Title
ELISA in Relapsed/Refractory MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed and refractory multiple myeloma who have had at least 2 prior lines of therapy, including immunomodulatory drugs and proteasome inhibitors
- Prior therapy with anti-CD38 and anti-B cell maturation antigen (BCMA) targets is allowed except an anti-BCMA T cell engager
- Patients cannot be refractory to an anti-CD38 antibody
- Measurable multiple myeloma defined by serum monoclonal protein ≥ 0.5 g/dL, or ≥ 200 mg monoclonal protein in urine, or serum free light chain ≥ 100 mg/L with abnormal kappa to lambda ratio
- Age 18 years or older
- Women of child-bearing potential must agree to use adequate contraception during and after study participation
- ECOG performance status 0 to 2
- Adequate organ and marrow function as defined by specified blood counts and liver and kidney function
- Participants with prior or concurrent malignancy not interfering with safety or efficacy assessment
- Cardiac function class 2B or better by New York Heart Association classification
- Ability to understand and sign informed consent
You will not qualify if you...
- Active plasma cell leukemia, POEMS syndrome, or amyloidosis
- Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease
- Ongoing Grade 2 or higher peripheral sensory or motor neuropathy
- History of Grade 2 or higher neuropathy with prior BCMA therapy, Guillain-Barré syndrome or variants, or Grade 3 or higher peripheral motor polyneuropathy
- Prior treatment with anti-BCMA bispecific T cell engager
- Current participation in other investigational agent studies
- Myeloma therapy or investigational drug within 2 weeks prior to treatment start or unresolved side effects from earlier treatments
- Known or suspected allergy to study drugs or device components
- Significant cardiovascular conditions within 6 months prior to enrollment including recent heart attack or arrhythmias
- Active infections such as hepatitis B, hepatitis C, HIV, or uncontrolled bacterial, fungal, or viral infections
- Other active malignancies within 3 years except certain skin or in situ cancers
- Recent major surgery or medical/psychiatric conditions increasing study risk or making participation inappropriate
- Live attenuated vaccine within 30 days before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable duration until disease progression, unacceptable toxicity, or withdrawal
Participants receive study drugs elranatamab and isatuximab administered subcutaneously using an investigational device, with the first dose potentially including a 2 to 8 day inpatient monitoring visit. This treatment continues until disease progression, unacceptable toxicity, or withdrawal.
Multiple visits during each 28-day cycle: Cycle 1 (Days 1, 4, 8, 15, 22), Cycles 2-6 (Days 1 and 15), Cycles 7+ (Day 1). The first dose may include a 2 to 8 day inpatient visit.
Duration - Up to 5 years post-treatment
After treatment ends, participants are followed every 3 months for up to 5 years to monitor health and disease status.
Visits every 3 months for up to 5 years
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet 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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