Elranatamab + Radiotherapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a low dose of radiation can enhance the effectiveness of elranatamab, a new potential drug, in killing cancer cells in people with multiple myeloma, a type of blood cancer. It targets individuals whose cancer has returned or did not respond well to previous treatments. Ideal candidates have multiple myeloma that worsened after stopping treatment and have visible tumors outside the bones that can be targeted with radiation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting the study. Specifically, you must not have taken investigational treatments within 14 days or 5 half-lives, whichever is less, and must stop IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic myeloma therapies at least 7 days before the first dose of the study drug.
Is there any evidence suggesting that elranatamab is likely to be safe for humans?
Research has shown that elranatamab is generally safe for people. Patients with relapsed or refractory multiple myeloma (RRMM) who used it did not encounter new safety issues compared to other treatments targeting the BCMA protein on cancer cells. Studies have found that even those with more severe disease had a safe experience with elranatamab. While all treatments carry risks, elranatamab has proven safe for many patients in previous trials.1234
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for multiple myeloma, which often involve combinations of chemotherapy, steroids, and immunomodulatory drugs, Elranatamab works by targeting a specific protein called BCMA on the surface of myeloma cells. This targeted approach allows it to engage the immune system more directly and efficiently, potentially leading to better outcomes. Researchers are particularly excited about Elranatamab because it is administered as a subcutaneous injection, which can be more convenient and less invasive than traditional intravenous treatments. Additionally, the combination of Elranatamab with radiotherapy is believed to enhance the immune system's response, offering a novel strategy that could improve the overall response rate compared to existing therapies.
What evidence suggests that this treatment might be an effective treatment for multiple myeloma?
Research has shown that elranatamab, which participants in this trial will receive, may effectively treat multiple myeloma, a type of blood cancer. One study found that 71% of patients treated with elranatamab saw their cancer improve. Another study reported a 65% improvement rate, with some patients experiencing significant or complete reduction of their cancer. When combined with another drug, elranatamab increased the improvement rate to 95.5% in certain patients. These findings suggest that elranatamab effectively fights multiple myeloma.5678
Who Is on the Research Team?
Christine Ye, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with a type of cancer called multiple myeloma that has come back or hasn't responded to treatment. They should have specific forms of the disease (EMD/PMD) and meet certain blood count and liver function criteria. It's not suitable for those who've had radiation on the same spots before.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive low doses of radiation therapy to enhance the effect of Elranatamab
Treatment
Participants receive Elranatamab (SubQ) every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elranatamab
Trial Overview
The study tests if low-dose radiation can make elranatamab, a drug for multiple myeloma, work better at killing cancer cells. Participants will receive both treatments as part of the research.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
To evaluate the efficacy of RT-induced immune priming to enhance Elranatamab (Elra) in RRMM with EMD or PMD as measured by overall response rate
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
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
1.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/136/554989/Real-world-outcomes-with-elranatamab-in-multipleReal-world outcomes with elranatamab in multiple myeloma
The overall response rate (ORR) was 65%, including ≥VGPR in 46% and ≥CR in 36%, consistent with MagnetisMM-3 (ORR 61%, ≥CR 35%; Lesokhin et al.
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 elranatamab ...
3.
onclive.com
onclive.com/view/elranatamab-plus-iberdomide-shows-early-efficacy-in-r-r-multiple-myelomaElranatamab Plus Iberdomide Shows Early Efficacy in R/R ...
Elranatamab plus iberdomide showed a 95.5% response rate in patients with BCMA-naive relapsed/refractory myeloma per early MagnetisMM-30 data.
Elranatamab for relapsed/refractory multiple myeloma
In this real-world cohort of 195 patients, elranatamab resulted in an ORR of 71% with an estimated median PFS and estimated median OS of 11.8 ...
Elranatamab Exposure–Safety Analysis in Relapsed or ... - PMC
An exposure–safety analysis was conducted using the data from patients with RRMM across four clinical studies, MagnetisMM‐1, 2, 3, and 9 ( ...
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/100/549688/Safety-and-efficacy-of-elranatamab-in-combinationSafety and efficacy of elranatamab in combination with ...
Safety and efficacy of elranatamab in combination with iberdomide in patients with relapsed or refractory multiple myeloma: Results from the ...
Efficacy and safety of elranatamab in patients with relapsed ...
In pts with RRMM and prior exposure to BCMA-directed therapies, elranatamab was efficacious and well tolerated; no new safety signals were observed vs the BCMA ...
Safety and Efficacy of Standard of Care (SOC) ...
Patients treated with SOC Elra had a favorable ORR (52.9%) while maintaining an acceptable safety profile despite a larger proportion of them having high risk ...
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