Assessing the safety of ABBV-383 in adults with relapsed or refractory multiple myeloma

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 adverse events associated with ABBV-383, an investigational drug, in adult participants suffering from relapsed or refractory multiple myeloma. The trial is structured into three arms, with Arm A focusing on dose optimization and expansion, while Arms B and C involve different treatment regimens based on prior therapies. Participants will receive intravenous infusions of ABBV-383, and the study aims to monitor changes in disease symptoms and any adverse reactions. The study is designed to gather critical data on the drug's efficacy and safety profile in this challenging patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have measurable disease as outlined in the protocol.
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C and Arm D: ECOG performance of \<= 1.
* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
* Must be naïve to treatment with etentamig (ABBV-383).
* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
* Arm E: Must have received 1 line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must have never received BCMA-targeted therapy.

Exclusion Criteria:

* Arm A: Received BCMA-targeted therapy.
* Arm C and Arm D: Rapidly progressing disease per investigator.

Where it's running

• Mayo Clinic Arizona /ID# 251405
  Phoenix, Arizona, United States Recruiting
• Highlands Oncology Group - Springdale /ID# 267742
  Springdale, Arkansas, United States Recruiting
• Rocky Mountain Cancer Centers - Aurora /ID# 268574
  Aurora, Colorado, United States Recruiting
• Medical Oncology Hematology Consultants /ID# 268560
  Newark, Delaware, United States Recruiting
• Hope And Healing Cancer Services /ID# 268536
  Hinsdale, Illinois, United States Recruiting
• Fort Wayne Medical Oncology And Hematology /ID# 268179
  Fort Wayne, Indiana, 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.

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

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.