Assessing the effects of Etentamig on AL Amyloidosis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of Etentamig (ABBV-383), an investigational drug, in adult participants diagnosed with immunoglobulin light chain (AL) amyloidosis. The trial is divided into two parts: a dose escalation phase to determine optimal dosing and a safety expansion phase to further assess the drug's effects. Participants will receive one of three doses during the first part, followed by one of two doses in the second part, with a total of around 76 participants expected to enroll. The study aims to monitor changes in disease activity and any adverse events associated with the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
* Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2.
* Have at least 1 organ historically impacted by AL amyloidosis.
* Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy.
* Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.

Exclusion Criteria:

* Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class.
* Participant has the following conditions:

  * Other non-AL amyloid disease;
  * Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium \> 11 mg/dL);
  * Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential);
  * Waldenström's macroglobulinemia;
  * Acute diffuse infiltrative pneumopathy;
  * Major surgery within 28 days prior first dose or planned during study participation;
  * History of organ transplant requiring continued use of immunosuppressants;
  * Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
  * Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.

Where it's running

• Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
  Miami, Florida, United States Recruiting
• Boston Medical Center /ID# 255066
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic - Rochester /ID# 255258
  Rochester, Minnesota, United States Recruiting
• Icahn School of Medicine at Mount Sinai /ID# 255408
  New York, New York, United States Recruiting
• Columbia University Medical Center /ID# 255068
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How well minimal residual disease is cleared in AL amyloidosis after first-line Dara-BorCyD

  This study tests whether achieving very good partial or complete marrow responses with Dara-BorCyD and planned stem cell transplant helps AL amyloidosis patients, by looking at minimal residual disease after treatment.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07215494

• Using daratumumab to treat patients with light chain amyloidosis

  This study is testing how well daratumumab works for treating light chain amyloidosis in different groups of patients to find the best way to help them.

  Recruiting Nanjing University School of Medicine · Nanjing, Jiangsu · NCT06376214

• Testing JNJ-79635322 for patients with advanced multiple myeloma or AL amyloidosis

  This study is testing a new drug called JNJ-79635322 to see how much of it is safe to give to people with advanced multiple myeloma or AL amyloidosis who haven't responded to other treatments.

  Recruiting at 25 sites Phase 1 Janssen Research & Development, LLC · Duarte, California and 28 other locations · NCT05652335

• Combining JNJ-79635322 with Daratumumab or Pomalidomide for Multiple Myeloma Treatment

  This study is testing a new drug called JNJ-79635322 combined with either daratumumab or pomalidomide to see how safe and effective it is for people with multiple myeloma.

  Recruiting at 16 sites Phase 1 Janssen Research & Development, LLC · Denver, Colorado and 15 other locations · NCT06768489

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.