46 Participants NeededMy employer runs this trial

Elranatamab + Tocilizumab for Multiple Myeloma

(CORE-MM Trial)

Recruiting at 5 trial locations
SC
Overseen BySarah Cannon Development Innovations, LLC
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: SCRI Development Innovations, LLC
Must be taking: HAART, VZV prophylaxis, PJP prophylaxis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

HL

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

I am at least 18 years old.
I agree not to donate sperm during the study and for 90 days after my last dose.
I have measurable signs of my disease based on blood, urine, or tumor size tests.
See 11 more

Exclusion Criteria

I have not had cancer treatment or clinical trial drugs in the past 12 weeks.
I have received a blood or platelet transfusion in the past 7 days.
I am not pregnant, nursing, or planning to become pregnant during or after the study.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive a single intravenous dose of tocilizumab followed by the first step-up dose of elranatamab to evaluate safety

4 weeks
1 visit (in-person) for tocilizumab, multiple visits for elranatamab administration

Treatment

Participants receive elranatamab subcutaneously each cycle, with cycles lasting 28 days

12 months
Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month
1 visit (in-person)

Survival Follow-up

Participants are followed for overall survival after the end of treatment

1 year

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

Group I: Safety Lead-in (Cohort 1)Experimental Treatment2 Interventions
Group II: Expansion (Cohort 2)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials
193
Recruited
13,800+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

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 ...

Real-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 ...

Elranatamab 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.

Quality 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 ...