104 Participants Needed

Elranatamab + Lenalidomide + Dexamethasone for Multiple Myeloma

DK
CO
Overseen ByCarl O Landgren, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Miami
Must be taking: Lenalidomide, Dexamethasone
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 aims to assess how a combination of three drugs—Elranatamab, Lenalidomide, and Dexamethasone—affects individuals newly diagnosed with multiple myeloma, a type of blood cancer. Researchers seek to determine if this combination can improve health outcomes. Individuals recently diagnosed with multiple myeloma who exhibit specific symptoms, such as bone pain or changes in blood tests, might be suitable candidates for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there is a 2-week washout period required for certain prior treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining elranatamab with lenalidomide and dexamethasone is generally safe and manageable for patients with newly diagnosed multiple myeloma. One study found this combination to be well-tolerated, although some common side effects occurred. These included low levels of white blood cells, red blood cells, and platelets, which are typical and expected with such treatments. Overall, the findings support the treatment's safety, though participants may still experience these side effects.12345

Why do researchers think this study treatment might be promising?

Elranatamab is unique because, unlike many standard treatments for multiple myeloma, it is a bispecific antibody that targets two different proteins on cancer cells. This dual-targeting approach allows it to more effectively engage the immune system to attack and destroy myeloma cells. Researchers are excited about Elranatamab because it offers a novel mechanism of action, potentially providing a more powerful and efficient way to treat multiple myeloma compared to traditional therapies like proteasome inhibitors and immunomodulatory drugs. By combining it with lenalidomide and dexamethasone, there's hope for enhanced treatment efficacy and improved patient outcomes.

What evidence suggests that this treatment might be an effective treatment for Multiple Myeloma?

Research has shown that combining Elranatamab, Lenalidomide, and Dexamethasone may help treat multiple myeloma. In studies, this treatment showed early positive results in newly diagnosed patients who cannot undergo transplants, suggesting it might effectively manage the disease. The combination likely works well by attacking cancer cells in different ways, potentially improving disease control. Although more information is needed, these early results offer promise for those considering this treatment option.45678

Who Is on the Research Team?

CO

Carl O Landgren, MD

Principal Investigator

Professor of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals newly diagnosed with Multiple Myeloma, a type of blood cancer. Participants should meet specific health criteria set by the study team but these are not detailed here.

Inclusion Criteria

I am not pregnant and agree to regular pregnancy tests during the study.
My condition has caused damage to my organs or other serious health issues.
I can take care of myself and am up and about more than 50% of my waking hours.
See 11 more

Exclusion Criteria

My cancer has spread to my brain or spinal cord.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study
I have a condition like HIV, hepatitis, COPD, asthma, COVID-19, or a heart problem.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Elranatamab in combination with Lenalidomide and Dexamethasone (ERd) for up to 24 cycles

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Elranatamab
Trial Overview The trial tests how effective Elranatamab combined with Lenalidomide and Dexamethasone is in treating new cases of Multiple Myeloma compared to standard treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Elranatamab in combination with lenalidomide and dexamethasone (ERd)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

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

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 ...
Elranatamab Plus Daratumumab/Lenalidomide Generates ...The combination of elranatamab, daratumumab, and lenalidomide showed promising efficacy in transplant-ineligible multiple myeloma patients, with ...
Initial results from MagnetisMM-6 part 1.A phase 3, open-label, randomized study evaluating the efficacy and safety of ELRA in combination with lenalidomide (R) ± daratumumab (DARA) (EDR or ER) vs ...
NCT05623020 | A Study to Learn About the Effects of ...... Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma.
DP122 | ELRANATAMAB IN COMBINATION WITH ...At data cutoff (DCO, Dec 23, 2024), the median follow-up was 4.6 mo (range, 1.2-6.2); treatment was ongoing in 33 pts. TEAEs were reported in ...
MagnetisMM-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.
Initial results from MagnetisMM-6 part 1.A phase 3, open-label, randomized study evaluating the efficacy and safety of ELRA in combination with lenalidomide (R) ± daratumumab (DARA) (EDR or ER) vs ...
Safety and efficacy of elranatamab in patients with relapsed ...Elranatamab elicits deep and rapid heme responses in patients with relapsed AL amyloidosis, including minimal residual disease negativity.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security