Elranatamab + Tocilizumab for Multiple Myeloma
(CORE-MM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug combination for multiple myeloma, a type of blood cancer that often recurs after treatment. Researchers aim to determine if adding tocilizumab can reduce cytokine release syndrome (CRS), a side effect that causes flu-like symptoms. Participants will receive the treatment in two phases to ensure safety and effectiveness. This trial may suit individuals whose multiple myeloma has returned after previous treatments, including lenalidomide and a specific type of antibody therapy, and who maintain manageable health overall. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take strong or moderate inducers of CYP3A4 (a liver enzyme) during the study, and any changes to HIV medications should be made well before starting the trial. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that elranatamab is generally well-tolerated by patients with multiple myeloma, a type of blood cancer. Research indicates that about 13% of patients experienced cytokine release syndrome (CRS), where the body reacts strongly, often with flu-like symptoms. Most patients developed CRS after their first or second dose of treatment.
When combined with tocilizumab, a medication used to manage CRS, the safety of elranatamab was still under investigation. Tocilizumab, already approved by the FDA for other conditions, has a well-established safety profile. Another study found that combining elranatamab with a different drug led to a good response rate, demonstrating its potential effectiveness.
Overall, while elranatamab can cause side effects like CRS, ongoing studies focus on managing these effects effectively.12345Why do researchers think this study treatment might be promising?
Elranatamab is unique because it introduces a new mechanism of action in the treatment of multiple myeloma. Unlike many current therapies that target cancer cells directly, elranatamab is a bispecific antibody that engages the body's immune system to attack the cancer by directing T-cells to the myeloma cells. This approach may offer a more targeted attack on the disease with potentially fewer side effects. Researchers are excited about its potential to enhance the body's natural defenses against multiple myeloma, offering hope for improved treatment outcomes.
What evidence suggests that this treatment might be an effective treatment for multiple myeloma?
Research has shown that elranatamab holds promise for treating relapsed or refractory multiple myeloma (RRMM), a type of blood cancer. In previous studies, 61% of patients responded to the treatment, with most seeing improvements in just over a month. Another study found that 65% of patients experienced a reduction in cancer activity. Additionally, 82% of those who responded maintained their improvement, demonstrating lasting benefits. In this trial, participants will receive tocilizumab, a medication that helps control inflammation, alongside elranatamab. This combination has been shown to keep side effects like cytokine release syndrome low, without reducing the treatment's effectiveness.12678
Who Is on the Research Team?
Hans Lee, MD
Principal Investigator
Sarah Cannon Research Institute (SCRI) Oncology Partners
Are You a Good Fit for This Trial?
This trial is for adults (18+) with multiple myeloma that has come back or not responded to treatment. Participants must have had at least one prior therapy, including lenalidomide and an anti-CD38 antibody, and be in good physical condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
Participants receive a single intravenous dose of tocilizumab followed by the first step-up dose of elranatamab to evaluate safety
Treatment
Participants receive elranatamab subcutaneously each cycle, with cycles lasting 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Survival Follow-up
Participants are followed for overall survival after the end of treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elranatamab
- Tocilizumab
Trial Overview
The study tests elranatamab given as an outpatient treatment for relapsed/refractory multiple myeloma. All participants receive a single preventive dose of tocilizumab before starting elranatamab to see if it reduces early side effects.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 6 participants will be enrolled into this Lead-In Cohort 1 to evaluate safety of regimen before proceeding to enroll into Expansion cohort.
Participants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 40 participants will be enrolled into this Expansion Cohort 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SCRI Development Innovations, LLC
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Tocilizumab prophylaxis for patients with multiple myeloma ...
Without compromising efficacy, a single dose of prophylactic tocilizumab resulted in low rates of CRS (10.1%) and ICANS (5.9%).
Elranatamab in relapsed or refractory multiple myeloma
The median duration of treatment was 5.6 months (range: 0.03–24.4 months), 48.0% were treated for at least 6 months and 35.8% for at least 12 ...
3.
cancernetwork.com
cancernetwork.com/view/real-world-elranatamab-maintains-responses-in-elderly-frail-r-r-multiple-myelomaReal-World Elranatamab Maintains Responses in Elderly ...
The overall response rate (ORR) with elranatamab was 65% (n = 81/125), with a very-good partial response (VGPR) or better rate of 46%, and a ...
NCT07637578 | A Study of Elranatamab Outpatient ...
This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts ...
May-June 2026: What's New in Myeloma?
Examined both efficacy and toxicity outcomes. Clinical trial data showed improvements in progression-free survival … combination therapy ...
NCT05927571 | A Study Evaluating the Safety, ...
The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II ...
7.
myeloma.org
myeloma.org/videos/elranatamab-combination-daratumumab-patients-relapsed-refractory-multiple-myeloma-phase-3Elranatamab in Combination with Daratumumab for Patients ...
The results showed that elranatamab was well tolerated and produced an overall response rate of 60.6% at the recommended phase 2 dose.
8.
oncpracticemanagement.com
oncpracticemanagement.com/special-issues/quality-improvement-strategies-to-optimize-outpatient-step-up-dosing-for-elranatamab-in-relapsed-refractory-multiple-myelomaQuality Improvement Strategies to Optimize Outpatient Step ...
Elranatamab is a bispecific antibody that targets BCMA, highly expressed on myeloma cells, and CD3 on T cells.15 By binding to both BCMA and CD3, elranatamab ...
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