Elranatamab +/- Dexamethasone for Multiple Myeloma
(MagnetisMM-9 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called elranatamab for individuals with multiple myeloma, a type of blood cancer that has recurred or hasn't responded to other treatments. The goal is to determine if starting with low doses and then increasing them is safe, and to identify the optimal dose and schedule for the medication. Participants will receive injections of elranatamab at the clinic, with visits potentially becoming less frequent over time. This trial may suit patients whose multiple myeloma did not respond to at least one previous treatment and who are experiencing a return of the disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering early access to potentially effective therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that elranatamab is generally safe and well-tolerated in people with multiple myeloma. Studies have found no new safety issues with its use. Some patients report side effects, but these are usually manageable. For example, one study found elranatamab safe when used alone or with other drugs, indicating that the treatment is manageable for most patients. Individual experiences can vary, so discussing any concerns with a healthcare provider is important.12345
Why are researchers excited about this study treatment for multiple myeloma?
Researchers are excited about Elranatamab for multiple myeloma because it uses a cutting-edge approach that targets BCMA, a protein found on the surface of myeloma cells. This is different from many current treatments, like proteasome inhibitors and immunomodulatory drugs, which have been the standard of care. Elranatamab is a bispecific antibody, meaning it can bind to two different targets at once, engaging both the cancer cell and the immune system to promote a stronger attack on the myeloma cells. This innovative mechanism has the potential to improve outcomes by offering a more direct and potentially more effective way to tackle the disease.
What evidence suggests that elranatamab might be an effective treatment for multiple myeloma?
Research has shown that elranatamab offers promising results for treating relapsed or refractory multiple myeloma, a type of blood cancer. In earlier studies, patients experienced strong and lasting improvements, with their cancer significantly reduced or even disappearing. Compared to other treatments used in everyday medical practice, elranatamab led to better outcomes. Notably, about 26% of patients achieved a complete response, showing no signs of cancer in their blood or urine after treatment. These findings suggest that elranatamab could be an effective option for this challenging condition. Participants in this trial will receive elranatamab, with some arms exploring different dosing strategies.16789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults with multiple myeloma that has returned or didn't respond to treatment. They must have measurable disease, not be pregnant, and agree to use contraception. Excluded are those with certain other cancers or conditions like active infections, recent stem cell transplant, previous anti-BCMA therapy, or known hypersensitivity to the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive elranatamab as an injection under the skin at the study clinic. Initial step-up doses followed by weekly doses.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes and survival
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Elranatamab
Trial Overview
The trial tests Elranatamab alone or combined with Dexamethasone in patients with relapsed/refractory multiple myeloma. It starts with low doses that increase over time (step-up dosing) and looks at safety and effectiveness of different doses and dose intervals over a minimum two-year participation.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
To explore higher dose intensity
Dose expansion
Dose determination
Evaluation of step-up priming dosing
Elranatamab is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead 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
Population Exposure-Response Efficacy Analysis of ...
Results from the MagnetisMM-3 study indicated deep and durable responses in patients with relapsed or refractory multiple myeloma (RRMM).
An Updated Indirect Comparison of Elranatamab Versus a ...
Patients treated with elranatamab exhibited significantly better clinical outcomes compared with treatments currently used in real-world clinical practice.
ELREXFIO® (elranatamab-bcmm) Results | Safety Info
In Group A, results with ELREXFIO showed: 26% of people had a CR or better: Multiple myeloma could not be detected in the blood or urine after treatment. 26% of ...
Comparison of outcomes with elranatamab and real world ...
This study aimed to characterise outcomes for real world TCE RRMM patients and to estimate the treatment effect of elranatamab compared to ...
A US subgroup analysis from MagnetisMM-3.
Background: The ongoing phase 2 MagnetisMM-3 (NCT04649359) study demonstrated the efficacy and safety of ELRA in patients (pts) with RRMM ...
Long‐term survival and safety of elranatamab in patients with ...
Elranatamab monotherapy continues to improve survival outcomes without new safety signals. ... multiple myeloma: phase 2 MagnetisMM‐3 trial results. Nat Med. 2023 ...
Comparison of outcomes with elranatamab and real world ...
This study provides recent real world evidence of poor outcomes in TCE RRMM in the UK. PFS was longer among patients who received ...
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cancernetwork.com
cancernetwork.com/view/magnetismm-6-data-suggest-safety-manageability-of-elranatamab-combo-in-ndmmMagnetisMM-6 Data Suggest Safety, Manageability of ...
Results from part 1 dose level G of the MagnetisMM-6 trial found elranatamab, daratumumab, and lenalidomide to be safe and manageable in NDMM.
Elranatamab in relapsed or refractory multiple myeloma
The results of this study are consistent with results reported from the phase 1 MagnetisMM-1 study in which a response rate of 64% and a median ...
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