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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital De Santa Maria E.P.E. Lisbon Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Region Skane Helsingborg Hospital Helsingborg Sweden
Region Dalarna Falun Sweden
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Universitaetsklinikum Krems Krems An Der Donau Austria
NU Hospital Group-Vaestra Goetalandsregionen Trollhattan Sweden
Centre Hospitalier D Avignon Avignon France
Evangelismos S.A. Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Hospital Universitario de Ourense Ourense Spain
Centre Hospitalier Universitaire d’Orléans Orléans France
Odense University Hospital Odense Denmark
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Klinikum Chemnitz gGmbH Chemnitz Germany
Semmelweis University Budapest Hungary
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario De Leon Leon Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universita’ Politecnica Delle Marche Ancona Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Centre Hospitalier De Saint-Quentin Saint Quentin France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Ostrava Ostrava Czechia
Uhitrktptp Mmnweda Cedalo Hytilmcifqhlcqica Hamburg Germany
Oskkeiyuicdczb Lweu Ghlx Linz Austria
Ciicvhv fce Helzcdkafex umm Ozkbskctc ak Bxndypudaotluwihpvgyh Frankfurt Germany
Achkoyj Orvwalqrbzr Uywpleraoehfv Cafqdicpkutx Dagot Sdkzke E Dgszb Snltpkw Dp Tnvuwu Turin Italy
Gjperzbvzfyzhhtwz Vaekbbdgr Pvdo Amkjie Evstplva Ozikpa Kqbwgo Gyor Hungary
Uwjbwxjypcdseq Cqzugdr Kgqxiraif Gdansk Poland
Umdkygkvtj Ddiiu Sqsxe Dz Rats Lh Sycdfpfz Rome Italy
Ipgjupsz Cvtmfr Dvvsvvszyatpbbtex L'hospitalet De Llobregat Spain
Ulexbgvzqv Glgxmtq Hbybcisy Ahwtnmf Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.07.2024
Belgium Belgium
Not recruiting
22.07.2024
Czechia Czechia
Not recruiting
22.07.2024
Denmark Denmark
Not recruiting
22.07.2024
France France
Not recruiting
22.07.2024
Germany Germany
Not recruiting
22.07.2024
Greece Greece
Not recruiting
22.07.2024
Hungary Hungary
Not recruiting
22.07.2024
Italy Italy
Not recruiting
22.07.2024
Poland Poland
Not recruiting
22.07.2024
Portugal Portugal
Not recruiting
22.07.2024
Spain Spain
Not recruiting
22.07.2024
Sweden Sweden
Not recruiting
22.07.2024

Trial locations

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.

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 ID:
2023-506668-15-00
Protocol code:
M22-574
Trial Phase:
Therapeutic confirmatory (Phase III)

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