Study Comparing Mezigdomide, Bortezomib, and Dexamethasone with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition known as Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is specifically looking at cases where the disease has either returned after treatment or has not responded to previous treatments, referred to as Relapsed or Refractory Multiple Myeloma. The trial aims to compare the safety and effectiveness of two different treatment combinations. One combination includes the medication Mezigdomide (also known by its code name CC-92480), along with Bortezomib and Dexamethasone. The other combination involves Pomalidomide (also known as CC-4047), together with Bortezomib and Dexamethasone.

The purpose of the study is to determine which treatment combination is more effective in managing the disease. Participants in the trial will be randomly assigned to receive one of the two treatment combinations. The study will monitor the participants over a period to observe how the disease progresses and to assess the safety of the treatments. The trial will also look at various outcomes, such as how long the disease remains under control, the overall survival of participants, and the quality of life during the treatment.

Throughout the study, participants will receive their assigned treatment and will be regularly checked by healthcare professionals to monitor their health and the effects of the treatment. The trial is designed to gather important information that could help improve treatment options for people with Multiple Myeloma in the future. Participants will be closely observed to ensure their safety and to collect data on how well the treatments work in controlling the disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

The assessment ensures that the patient has a documented diagnosis of multiple myeloma and meets specific health criteria.

2 randomization

The patient is randomly assigned to one of two treatment groups. This process is essential to compare the effectiveness of the two treatment regimens.

3 treatment phase

The patient receives one of the following treatment combinations:

Group 1: Mezigdomide (CC-92480), Bortezomib, and Dexamethasone.

Group 2: Pomalidomide, Bortezomib, and Dexamethasone.

Medications are administered as follows:

Mezigdomide and Pomalidomide are taken orally in capsule form. Dosages vary based on the specific medication and patient needs.

Bortezomib is administered as a subcutaneous injection.

Dexamethasone is taken orally in tablet form or administered intravenously as a solution for injection.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment and any side effects.

This includes routine blood tests, imaging studies, and health assessments.

5 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation is performed to determine the effectiveness of the treatment.

This includes measuring progression-free survival and other health outcomes.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of Multiple Myeloma and measurable disease. This means that certain proteins in the blood or urine are at specific levels, or there are abnormal levels of certain light chains in the blood.
  • The patient should have received 1 to 3 previous treatments for Multiple Myeloma.
  • The patient must have been treated with a medication regimen that included lenalidomide in the past.
  • The patient must have shown at least a minimal improvement in their condition from at least one previous treatment for Multiple Myeloma.
  • The patient must have experienced a worsening of their disease during or after their last treatment for Multiple Myeloma.
  • The patient must have an ECOG performance status score of 0, 1, or 2. This score is a way to measure how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Both male and female patients are eligible to participate.
  • The study includes patients who may be considered vulnerable, meaning they might need extra care or protection.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than relapsed or refractory multiple myeloma cannot participate. This means the study is only for those whose multiple myeloma has returned or did not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain other health conditions that might interfere with the study cannot participate. This is to ensure the safety of the participants and the accuracy of the study results.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
  • Patients who have allergies or reactions to the study medications cannot participate. This is to prevent any harmful effects.
  • Patients who have not recovered from previous treatments or surgeries may not be eligible. This is to ensure participants are in a stable condition before starting the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre Hospitalier Universitaire De Nimes Nimes France
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Hospital San Pedro De Alcantara Caceres Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Vitaz Sint-Niklaas Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Universitaetsklinikum Krems Krems An Der Donau Austria
MVZ Nordoberpfalz GmbH Weiden I.D.Opf. Germany
Haematologisch Onkologische Schwerpunktpraxis Wuerzburg Germany
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Pratia Hematologia Sp. z o.o. Katowice Poland
Institutul Regional De Oncologie Iasi Iasi Romania
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Philipps-Universitaet Marburg Marburg Germany
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
Champalimaud Clinical Centre Lisbon Portugal
University Hospital Galway Galway Ireland
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hospital Universitario De Leon Leon Spain
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Gasthuiszusters Antwerpen Antwerp Belgium
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Kliniken Suedostbayern AG Traunstein Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Ziekenhuis Oost Limburg Genk Belgium
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH Bamberg Germany
Hospital Costa del Sol Marbella Spain
Fundeni Clinical Institute Bucharest Romania
Praxis Onkologie am Raschplatz Hannover Hanover Germany
Cmqvsa Ltzi Bxikii Lyon France
Uitzhmfiei Mcmxmbs Cgtvbd Hslvagqadvqrvbgze Hamburg Germany
Cufm Unrokffnun Hhmefdzl Cork Ireland
Snqkpvburzybvbqk Kgnxghcifbfruiea Ghtqfnscpo Leoben Austria
Mvfx Cctwboy Mwiomugg Trugo Torun Poland
Cullfy Hqdvwmuukoh Eq Uxusgdgityvnj Dj Lujhxxa Limoges France
Iijklruh Ronkjawlq Pmb Ls Sfzsbg Day Tfkvoj Dbza Aggnpll Ijzr Sukvfo Meldola Italy
Hmmmamyc Ucxxlyrbdl Cilngux Hxvogfif Helsinki Finland
Ctrtnm Hyoygmlqkht Rhvhrusg Uyhsryfsrvgsu Dk Tnlgl Tours France
Ajsvbxm Ujofv Szptwqgom Lywgeo Dk Bjhmrma Bologna Italy
Htjsmysd Uxmgngdsqrqtjl Shplveafil &iapydt Hjxdlpi dx Hopqwcrdbyk STRASBOURG, Alsace France
Egajkiqdwyvdnhiektwgzhcqtv Hbgrfrum og Ajptty 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
20.09.2022
Belgium Belgium
Not recruiting
20.09.2022
Czechia Czechia
Not recruiting
20.09.2022
Finland Finland
Not recruiting
20.09.2022
France France
Not recruiting
20.09.2022
Germany Germany
Recruiting
20.09.2022
Greece Greece
Not recruiting
20.09.2022
Ireland Ireland
Not recruiting
20.09.2022
Italy Italy
Not recruiting
20.09.2022
Poland Poland
Not recruiting
20.09.2022
Portugal Portugal
Not recruiting
20.09.2022
Romania Romania
Not recruiting
20.09.2022
Spain Spain
Not recruiting
20.09.2022

Trial locations

Mezigdomide (CC-92480) is an experimental medication being tested for its effectiveness in treating multiple myeloma, a type of blood cancer. It is being studied to see if it can help stop the cancer from growing or spreading in patients whose cancer has returned or did not respond to previous treatments.

Bortezomib is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, which are eventually destroyed. It is often used in combination with other medications to enhance its effectiveness.

Dexamethasone is a type of steroid medication that helps reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to help control the symptoms and improve the effectiveness of other cancer treatments.

Pomalidomide is a medication used to treat multiple myeloma, especially in patients who have not responded to other treatments. It works by helping the immune system attack cancer cells and by stopping the growth of these cells.

Relapsed or Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has either returned after treatment (relapsed) or has not responded to treatment (refractory). It typically leads to an overproduction of abnormal plasma cells, which can crowd out healthy blood cells. This can result in symptoms such as bone pain, anemia, kidney problems, and increased risk of infections. The disease progresses as these abnormal cells continue to multiply, potentially causing damage to bones and other organs. Managing the progression of this disease often involves monitoring and adjusting treatment strategies to control the growth of cancerous cells.

Trial ID:
2023-509859-13-00
Protocol code:
CA057-001
Trial Phase:
Therapeutic confirmatory (Phase III)

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