Elranatamab for AL Amyloidosis

Not yet recruiting at 1 trial location
SM
Overseen BySandra Mazzoni, DO
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 new immunotherapy drug, elranatamab, for individuals recently diagnosed with AL amyloidosis, a condition where abnormal proteins accumulate in organs. The researchers aim to determine if this drug can clear these proteins and improve organ function using two different dosing schedules. Suitable candidates for this trial include those newly diagnosed with AL amyloidosis who have not yet started treatment. Participants will receive the drug via injections over a 6-month period and will be monitored for up to 2 years after treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation 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 for people with AL amyloidosis. In earlier studies, patients experienced no new or unexpected side effects, even those with serious heart problems. This indicates the drug's safety, as no unusual issues emerged. Elranatamab has demonstrated good results in managing the disease, with many patients responding well to the treatment. Prospective participants should discuss any concerns with the study team, who can provide more personalized information.12345

Why are researchers excited about this trial's treatment?

Elranatamab is unique because it targets BCMA, a protein found on the surface of certain cancer cells in AL Amyloidosis, using a bispecific antibody approach. Unlike traditional treatments such as chemotherapy and steroids, which can be harsh on the body, Elranatamab directly engages the immune system to attack these cells, potentially offering a more targeted and less toxic treatment option. Researchers are excited about this mechanism because it represents a new way to treat the disease, focusing on precision and potentially improving patient outcomes with fewer side effects.

What evidence suggests that elranatamab might be an effective treatment for AL amyloidosis?

Research has shown that elranatamab may help treat AL amyloidosis. In earlier studies with patients whose AL amyloidosis returned or didn't respond to treatment, all participants showed improvement, and 67% achieved a complete response. In this trial, participants will join either Arm A or Arm B, both involving elranatamab with different dose schedules. Elranatamab aids the immune system in targeting and fighting the abnormal cells causing the disease. It has demonstrated quick and strong results while remaining generally safe. These findings suggest that elranatamab could effectively achieve significant remissions in AL amyloidosis.23456

Who Is on the Research Team?

SM

Sandra Mazzoni, DO

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) newly diagnosed with AL amyloidosis who haven't had prior treatment, have good organ function, and are not pregnant or breastfeeding. People with advanced heart involvement, certain cancers, serious infections like HIV, or other major health issues can't join.

Inclusion Criteria

Participants must have a clonal plasma cell burden of less than 40%
I have newly diagnosed AL amyloidosis and have not had any treatment yet.
I am 18 years old or older.
See 10 more

Exclusion Criteria

Participants who are receiving any other investigational agents for this condition
I have Stage IIIB amyloidosis based on the 2004 Mayo Clinic criteria.
Participants with active clinically significant autoimmune diseases
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elranatamab as a series of injections over 6 treatment cycles, approximately 6 months

6 months
Regular visits for blood tests, physical exams, bone marrow biopsies, and heart assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up visits for up to 2 years, with an option to extend to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Elranatamab

Trial Overview

The study tests elranatamab (an experimental immunotherapy) given by injection to see if it helps people with newly diagnosed AL amyloidosis. Participants are randomly assigned to one of two dosing schedules over about 6 months, followed by up to 2 years of follow-up.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm B: SUD followed by Arm B dose schedulingExperimental Treatment1 Intervention
Group II: Arm A: SUD followed by Arm A dose schedulingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40712156/

Safety and efficacy of elranatamab in patients with relapsed ...

We treated 9 consecutive patients with advanced-stage AL amyloidosis with single-agent elranatamab, observing a 100% overall response and 67% ...

Elranatamab May Be Effective for Light Chain Amyloidosis

The median progression-free survival was 8.2 months. Free light chain suppression was achieved within the first treatment cycle. In addition, 5 ...

Safety and Efficacy of Elranatamab in Patients with Relapsed ...

There are currently no published data regarding the safety and efficacy of Elra in patients with AL amyloidosis. Methods: 3 adult pts with ...

A phase I/II, open label, Study to evaluate safety, tolerability ...

... AL amyloidosis, elranatamab has demonstrated no new safety signals while showing promising efficacy. Data regarding longevity and predictive ...

NCT06569147 | Elranatamab in Patients With Relapsed or ...

This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis. Detailed Description. This ...

Safety and efficacy of elranatamab in patients with relapsed ...

No new adverse events were noted in patients with AL amyloidosis treated with elranatamab, including in patients with advanced heart failure.