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Study Comparing ABBV-383 with Standard Therapies for Adults with Relapsed or Refractory Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Relapsed or Refractory Multiple Myeloma (RRMM), which is a type of blood cancer that has returned or is not responding to treatment. The study will compare a new treatment called ABBV-383 with other standard treatments that are currently available. ABBV-383 is a type of medication known as a monoclonal antibody, which is designed to target specific proteins on cancer cells. The purpose of the study is to evaluate how effective and safe ABBV-383 is when used alone in treating adults with RRMM who have already tried at least two other treatments.

Participants in the study will receive either ABBV-383 or one of the standard available therapies, which may include medications like Dexamethasone, Bortezomib, Carfilzomib, Pomalidomide, Selinexor, or Elotuzumab. Some participants may also receive a placebo. The study will last for up to 12 months, during which participants will be monitored regularly to assess their response to the treatment and any side effects they may experience. The study aims to understand how well the treatments work in stopping the progression of the disease and improving overall survival rates.

Throughout the study, participants will undergo various assessments to track their health and the effectiveness of the treatment. These assessments will include regular check-ups and tests to measure the size and activity of the cancer. The study will also collect information on how the treatment affects participants' quality of life, including their physical functioning and fatigue levels. The results of this study will help determine if ABBV-383 can be a beneficial treatment option for people with RRMM.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, previous treatment history, and current health status.

    A fresh bone marrow sample or a recent archival sample is required before starting the treatment.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of ABBV-383 as a monotherapy for relapsed or refractory multiple myeloma.

    The medication is given through an intravenous infusion.

  3. Step 3

    Medication administration

    Additional medications may be administered to manage symptoms and support treatment, including dexamethasone, paracetamol, and diphenhydramine.

    These medications are given either orally or intravenously, depending on the specific drug.

  4. Step 4

    Monitoring and assessments

    Regular monitoring of health status and response to treatment is conducted.

    Assessments include measuring disease progression and response rates using established criteria.

  5. Step 5

    Ongoing evaluations

    Evaluations of overall survival, symptom changes, and physical functioning are performed periodically.

    Patient-reported outcomes are collected to assess quality of life and treatment impact.

  6. Step 6

    Completion of study

    The study is expected to continue until December 2027, with ongoing assessments and data collection throughout the duration.

    Final evaluations will determine the overall effectiveness and safety of the treatment.

Who can join the trial?

10 criteria

  • Adult individuals, both male and female, who are **18 years old** or older.
  • The patient must be eligible to receive the doctor's choice of **Standard Available Therapies (SAT)** based on approved guidelines and their previous treatment history for multiple myeloma.
  • The patient must agree to be treated with one of the specified **Standard Available Therapies (SAT)**, chosen by the doctor based on local care standards.
  • The patient must agree to a fresh **bone marrow tumor sample** and biopsy before treatment or have a suitable previous sample taken within 12 weeks before the first dose, without any treatment in between.
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of **2 or less**. This is a scale that measures how well a patient can perform daily activities.
  • The patient must meet specific **laboratory test results** as outlined in the study protocol within 2 weeks before the first dose of the study drug.
  • The patient must have a diagnosis of **relapsed and/or refractory multiple myeloma** during or after their last treatment. This means the disease has returned or is not responding to treatment.
  • The patient must have **measurable disease** within 28 days before being assigned to a treatment group. This can be measured by certain proteins in the blood or urine, or by other specific tests if these proteins are not measurable.
  • The patient must have received at least **2 or more lines of therapy**, including treatment with a **proteasome inhibitor (PI)**, an **immunomodulatory drug (IMiD)**, and an **anti-CD38 monoclonal antibody (mAb)**. These are types of treatments used for multiple myeloma.
  • Patients with known **HIV** can participate if they have an undetectable HIV viral load while on antiretroviral medication and can tolerate the study treatment according to the doctor's judgment.

Who cannot join the trial?

6 criteria

  • Patients who have not received at least 2 previous treatments for their condition.
  • Patients who have not been treated with a PI (proteasome inhibitor), an IMiD (immunomodulatory drug), and an anti-CD38 mAb (a type of medication that targets specific proteins on cancer cells).
  • Patients who are not adults.
  • Patients who are not part of the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

ABBV-383 is an investigational medication being studied for its effectiveness, safety, and tolerability in treating adults with relapsed or refractory multiple myeloma. This medication is being tested as a single treatment option for patients who have already undergone at least two previous treatments, which included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. The goal of the study is to determine how well ABBV-383 works in managing this type of cancer compared to other standard treatments available.

What is already known about the treatment

ABBV-383 – This medication is administered as a monotherapy for patients with relapsed or refractory multiple myeloma, typically after they have undergone at least two previous treatments. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness, safety, and tolerability compared to standard therapies. ABBV-383 is designed to target specific proteins on cancer cells, helping the immune system to identify and destroy these cells. It falls under the pharmacological classification of monoclonal antibodies, which are engineered to bind to specific antigens found on the surface of cancer cells.

Investigated diseases

Relapsed or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease has returned after treatment or does not respond to standard therapies. It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can become more aggressive over time, making it challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506668-15-00Protocol codeM22-574Estimated enrolment414 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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