Study to Compare Mezigdomide, Carfilzomib, 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 Relapsed or Refractory Multiple Myeloma (RRMM), which is a type of cancer that affects plasma cells in the bone marrow. The study is evaluating a new treatment combination that includes the medications Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone. These medications are being tested to see if they can help patients with RRMM who have not responded to previous treatments or whose disease has returned after treatment.

The purpose of the study is to compare the effectiveness of the combination of Mezigdomide, Carfilzomib, and Dexamethasone against the combination of Carfilzomib and Dexamethasone alone. Participants in the study will be randomly assigned to receive either the three-drug combination or the two-drug combination. The study will monitor participants over a period of time to see how long they can live without their disease getting worse, which is known as progression-free survival.

Throughout the study, participants will receive their assigned treatment and will have regular check-ups to monitor their health and the status of their multiple myeloma. The study aims to provide valuable information on whether adding Mezigdomide to the existing treatment can offer better outcomes for patients with RRMM. This research is part of ongoing efforts to find more effective treatments for this challenging condition.

1 joining the study

Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive a combination of mezigdomide, carfilzomib, and dexamethasone, while the other group will receive only carfilzomib and dexamethasone.

2 medication administration

Participants in the first group will take mezigdomide orally in capsule form. The dosage may vary, including options such as 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg, 0.8 mg, or 1 mg. The specific dosage and frequency will be determined by the study team.

All participants will receive carfilzomib through an intravenous infusion. The dosage is 60 mg, and the frequency will be specified by the study team.

Participants will also take dexamethasone orally in capsule form. The dosage and frequency will be determined by the study team.

3 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This will include medical examinations, blood tests, and other necessary evaluations.

Participants will be required to attend scheduled follow-up visits as determined by the study team to ensure safety and track progress.

4 completion of the study

The study is expected to continue until July 2029. Participants will be informed about the completion of their involvement in the study and any necessary post-study procedures.

Who Can Join the Study?

  • The participant must have a documented diagnosis of multiple myeloma and measurable disease. This means the disease can be measured in the blood or urine using specific tests.
  • The participant must have received at least one previous treatment for multiple myeloma.
  • The participant must have been treated before with a drug called lenalidomide and a type of medicine known as an anti-CD38 monoclonal antibody.
  • The participant must have shown at least a minimal response to at least one previous treatment for multiple myeloma. A minimal response means the disease showed some improvement.
  • The participant must have experienced disease progression, meaning the disease got worse, during or after their last treatment for multiple myeloma.
  • The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. This score is used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but able to do most self-care activities.
  • The study is open to both male and female participants.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. This is a type of blood cancer that has returned or does not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to both male and female participants.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Of Pecs Pecs Hungary
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Oslo Universitetssykehus HF Oslo Norway
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Amphia Hospital Breda The Netherlands
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
General University Hospital Of Patras Patras Greece
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH Munich Germany
Semmelweis University Budapest Hungary
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH Dortmund Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Klinikum Nuernberg Nürnberg Germany
Ospedale Vito Fazzi Lecce Lecce Italy
University Of Debrecen Debrecen Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
Semmelweis University Budapest Hungary
Universita’ Di Pisa Pisa Italy
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
Region Midtjylland Aarhus Denmark
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Hospital Universitario De Canarias La Laguna Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Virgen De Las Nieves Granada Spain
Medisch Spectrum Twente Enschede The Netherlands
Odense University Hospital Odense Denmark
Fundeni Clinical Institute Bucharest Romania
Zealand University Hospital, Department of Cardiology Roskilde Denmark
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH Vienna Austria
Azienda Ospedaliera Pugliese Ciaccio Catanzaro Italy
Hvxmc Balxpp Hu Bergen Norway
Hieua Snojjokox Hf Stavanger Norway
Slbmiqydchjrvk ap Rmbzvsespb Hanover Germany
Idvjggjm Rqsamkxpb Pnr Ll Sasjoq Dnk Toeava Dlyx Aqfmrpb Ihaq Slklnz Meldola Italy
Uurzqnfefqkapxjjyqzvt Wllemutoa Atb Wuerzburg Germany
Akmxvkz Usnha Sxuloftux Lboszd Dh Bijmqjv Bologna Italy
Optiffnewlorvq Leny Gsqi Linz Austria
Ihscfayt Caaack Daauprmdgpejytfbn L'hospitalet De Llobregat Spain
Fsxuemfax Palg Lf Ioygzjevbiyoq Brzmmsmzu Dro Hxbvyjjm Uvvonjveldvaf Lf Poh Madrid Spain
Hmzwvkif Uvwpossdfrans Hrtajfrk Ttluy y Pbmowf Ieyaxjcy Cxokzw drrpperobajgzysyl (pofl Badalona Spain
Hoffyyrp Veuk dghsdsal Barcelona Spain
Amjzrpl Rqeqfwh Sjswqf Constanta Romania

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
30.09.2022
Bulgaria Bulgaria
Not recruiting
30.09.2022
Denmark Denmark
Not recruiting
30.09.2022
Germany Germany
Not recruiting
30.09.2022
Greece Greece
Not recruiting
30.09.2022
Hungary Hungary
Not recruiting
30.09.2022
Italy Italy
Not recruiting
30.09.2022
Norway Norway
Not recruiting
30.09.2022
Romania Romania
Not recruiting
30.09.2022
Spain Spain
Not recruiting
30.09.2022
The Netherlands The Netherlands
Not recruiting
30.09.2022

Trial locations

Mezigdomide (CC-92480/BMS-986348) is a new medication being tested in this study. It is designed to help treat multiple myeloma, a type of blood cancer, especially in patients whose cancer has returned or has not responded to previous treatments. Mezigdomide works by targeting and destroying cancer cells, which may help slow down or stop the progression of the disease.

Carfilzomib is a medication used to treat multiple myeloma. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting proteasomes, carfilzomib causes a buildup of proteins in cancer cells, leading to their death. This helps to control the growth and spread of the cancer.

Dexamethasone is a type of steroid medication that is often used in combination with other cancer treatments. It helps reduce inflammation and can also help kill cancer cells. In the context of multiple myeloma, dexamethasone is used to enhance the effectiveness of other treatments and manage symptoms associated with the disease.

Relapsed or Refractory Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed or refractory multiple myeloma, the disease has returned after treatment or does not respond to therapy. The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Over time, these cancerous cells crowd out healthy blood cells, causing anemia and increased risk of infections. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The progression of the disease can vary, with periods of stability followed by worsening symptoms.

Trial ID:
2022-500861-29-00
Protocol code:
CA057-008
Trial Phase:
Therapeutic confirmatory (Phase III)

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