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

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
Fundeni Clinical Institute Bucharest Romania
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH Munich Germany
Amphia Hospital Breda The Netherlands
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Hospital Universitario De Canarias La Laguna Spain
Koejkukw Ntlbkieai Nürnberg Germany
Ugukleugzr Os Dbcyhcpi Debrecen Hungary
Hztblwlv Voci dcsjovlj Barcelona Spain
Zbxtwxd Ukpmdzbuca Hsnrunmgw Dixdntknhj op Cgitjzstmx Roskilde Denmark
Oswucr Ucinmqekdr Hjijsfxt Odense Denmark
Ffmrzjgugn Iqibx Cd Gvfkic Owafrftb Mucywxpv Puqsruwgpnt Milan Italy
Iyvgnjje Rfdhpcfnb Ple Lb Sllucb Dng Tygnzz Dxav Adkyyln Iwqn Simcau Meldola Italy
Anvqmowvh Hbvuuoqb Athens Greece
Hqbcr Bkomom Hr Bergen Norway
Ctulmad Ubplqecznjrcjqjbnplw Bwypbm Kmb Berlin Germany
Gotuifz Uryvvdhkgy Hrokffnj Oy Pjxeem Patras Greece
Uvvrzjhslnlvuwltupbbh Hwdegfqkxw Agc Heidelberg Germany
Uoffdqpukrjmfewoqwobd Wluhghmts Aor Wuerzburg Germany
Rxszlc Mfoptlskgnf Aarhus Denmark
Ugqyfvhflgjm Lwmaxbx Leipzig Germany
Arjgale Uktbu Srkppvztw Lttzqj Db Bpwivoq Bologna Italy
Oisifhcaaiyxxb Luun Gqit Linz Austria
Iopzhdii fvhd Khlfuzbhy Txrafstrqstrdtaazbx uby Ipnmaxpphvqu Unq gsbfd Ulm Germany
Uwbpgzzpgeqombcvhyijb Smygwpreczwrwxqbpy Aii Kiel Germany
Arwbmwv Svbzvasdo Uxtanrxhqeujy Fuhekf Cmqbhfvu Udine Italy
Huybvgsc Uvheiqhdxdtwi Piqynl Dw Hrkmvk Dh Mrxcflbevrs Majadahonda Spain
Iwsciwlv Cjsevg Dgdliwzifgwwtsucn L'hospitalet De Llobregat Spain
Fautwffim Pzdc Lw Inohqbtfpzqii Bhkdxjpdn Dwk Hjpvbyul Ugixevbydaenp Ld Pyl Madrid Spain
Gryxha Nxnawudcio Tzxxlkmovodpr Glapga Pxvmejclmizr Thessaloniki Greece
Hkidyrtx Uccqswcqttxlv Vpewer Da Lii Nslvco Granada Spain
Momzjtq Seppzzwj Txgipx Enschede The Netherlands
Unbdvvapbm Mdugnxkkzhdj Hcflmedg Fet Ahxpoj Tjwmbyirg Snplj Grywjn Edv Plovdiv Bulgaria
Oqjvjyca Vlhn Fxmdt Lxqlu Lecce Italy
Hjfww Sraqczjhr Hr Stavanger Norway
Ayhtsaf Rphhdkf Sgbcjs Constanta Romania
Sevunhrsuzhkvu am Rynsdsdydw Hanover Germany
Mbjcuw Hnkbulmd Ducayygmwfv Gktg Duesseldorf Germany
Udluoyflqnvyggjxr Ds Paej Pisa Italy
Sozusdixitptfcdyvutwjf Vrrzhiceo Omtgoigxyqgo Nyiregyhaza Hungary
Svyuihaabd Usupbbcknn Budapest Hungary
Syqqinxy Cmgumf Jhwgzkyz Dl Ungkmmm Silkb Sibiu Romania
Gpxsp Gzxrgnynbwmt fxha ogwzcunqvmzh Sxshngr Dthfvgrt mrf Dortmund Germany
Hykphjyh Uxphysabizcot Hbxgsvuq Tdjzu y Pzatxa Irbeexcr Cvlicy dpjetsciziliypvef (zxhs Badalona Spain
Ksheqhfwaul Dkc Bvikmdnmcugh Snungnrmif Wsts Bppjujqshmnenqtsmeaq mbb Vienna Austria
Azgaqrg Oansgauozvq Pxooiqvd Cmeffzd Catanzaro Italy

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.

Investigated Diseases:

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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