Study Comparing BMS-986393 CAR T Cell Therapy to Standard Treatments for Adults with Relapsed or Refractory Multiple Myeloma Resistant to Lenalidomide

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What is this study about?

This clinical trial is focused on studying a treatment for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically for patients whose disease has returned or has not responded to previous treatments, including a medication called Lenalidomide. The main treatment being tested is a new type of therapy called BMS-986393, also known as GPRC5D-directed CAR T Cell Therapy. This therapy involves using a patient’s own T-cells, which are a type of immune cell, that have been modified to better recognize and attack cancer cells. The study will compare this new treatment to standard treatments, which include combinations of drugs like Daratumumab, Pomalidomide, and Dexamethasone, or Carfilzomib with Dexamethasone.

The purpose of the study is to determine if the new therapy works better than the standard treatments. Participants will receive either the new therapy or one of the standard treatments. The study will monitor how long participants live without their cancer getting worse and whether they achieve a state where no signs of cancer can be found in their body. The study will also look at overall survival, which is the average time participants are alive after starting the study, and how many participants show a positive response to the treatment.

Participants in the study will be adults who have received 1-3 previous treatments for Multiple Myeloma and have evidence that their disease worsened during or after their last treatment. The study will take place over several years, with an estimated end date in 2032. The goal is to find out if the new therapy can provide better outcomes for patients with this challenging condition.

1 joining the study

Upon joining the study, you will be assigned to one of two groups. One group will receive the new treatment called BMS-986393, a type of therapy that uses your own cells to fight the disease. The other group will receive standard treatments, which may include a combination of medications such as daratumumab, pomalidomide, and dexamethasone or carfilzomib with dexamethasone.

2 treatment administration

If you are in the group receiving BMS-986393, the treatment will be given through an intravenous infusion, which means it will be delivered directly into your bloodstream through a vein. This process involves collecting your cells, modifying them in a laboratory, and then infusing them back into your body.

If you are in the standard treatment group, you will receive medications as follows: daratumumab is given as a subcutaneous injection, pomalidomide is taken orally, and dexamethasone is taken orally or intravenously. Carfilzomib is administered intravenously.

3 monitoring and follow-up

Throughout the study, regular check-ups will be conducted to monitor your health and the effectiveness of the treatment. This includes blood tests, imaging tests, and other assessments as needed.

The study aims to measure how long you live without the disease getting worse and whether there are no signs of the disease in your body after treatment.

4 end of study participation

Your participation in the study will continue until the study ends or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is June 21, 2032.

Who Can Join the Study?

  • Have Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (RRMM). This means the multiple myeloma has returned or did not respond to previous treatments, including a specific drug called Lenalidomide.
  • Have received 1-3 previous treatments for multiple myeloma, and the disease got worse during or after the last treatment.
  • Have measurable signs of multiple myeloma according to the study’s criteria.
  • Be at least 18 years old.
  • Have adequate organ function and performance status as per the study’s criteria. This means your organs are working well enough, and you are physically able to participate in the study.

Who Cannot Join the Study?

  • Patients who have not experienced a return or worsening of their Multiple Myeloma after treatment with Lenalidomide cannot participate. Multiple Myeloma is a type of blood cancer, and Lenalidomide is a medication used to treat it.
  • Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, 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
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Universitaet Leipzig Leipzig Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Oulu University Hospital Oulu Finland
Hospital Universitario Virgen De Las Nieves Granada Spain
Evangelismos S.A. Athens Greece
University Of Debrecen Debrecen Hungary
Institutul Regional De Oncologie Iasi Iasi Romania
Odense University Hospital Odense Denmark
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Klinikum Chemnitz gGmbH Chemnitz Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Universidade De Santiago De Compostela Santiago De Compostela Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fundeni Clinical Institute Bucharest Romania
Cpdzzgcoi Uvbjbcdnmlujwv Sxvctnrfe Woluwe-Saint-Lambert Belgium
Uokcqyqfft Meqbdkj Cbnqoi Hsoecjyhbxfopwtsc Hamburg Germany
Oqbwpexzdfnyzk Lash Gney Linz Austria
Wmdqsewdtsl Wwoabrgtkqotrnzyxvtx Cfufzcm Omphifxzh I Tvpssfmiuwygz Im Mkztxsyvenf W Ldois Lodz Poland
Aciptjfom Ulk Amsterdam The Netherlands
Hrrpggwo Uawntxlapk Csjuctu Hevvacrg Helsinki Finland
Alwjmuv Ojlkeggdjbp Uuoyiiayltxpk Cvyvrwximbzh Drzbh Sbjjvm E Dawpr Sgyzynt Dr Twjrly Turin Italy
Uwblvqhoktoxvoybgisxp Wmczzqblb Arn Wuerzburg Germany
Apwbiea Uayfd Sxebwawnr Ljfyoo Df Bcfbaae Bologna Italy
Ukrjbmeeqqntyd Czppvbp Kwqpsmusj Gdansk Poland
Ujuaeuygpu Ot Anfcvso Edegem Belgium
Inipxveb Coosib Dyocfxzhsaxyarhch L'hospitalet De Llobregat Spain
Hkvyrtx Hinur Mmhiow &njwqdm 1 rud Gimglww Ebfhbm Creteil France
Ufquwpskuh Gukfmhe Hbebnbxm Apjuxvw 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
Recruiting
01.04.2025
Belgium Belgium
Recruiting
01.04.2025
Czechia Czechia
Recruiting
01.04.2025
Denmark Denmark
Recruiting
01.04.2025
Finland Finland
Recruiting
01.04.2025
France France
Recruiting
01.04.2025
Germany Germany
Recruiting
01.04.2025
Greece Greece
Recruiting
01.04.2025
Hungary Hungary
Recruiting
01.04.2025
Italy Italy
Recruiting
01.04.2025
Norway Norway
Recruiting
01.04.2025
Poland Poland
Recruiting
01.04.2025
Portugal Portugal
Recruiting
01.04.2025
Romania Romania
Recruiting
01.04.2025
Spain Spain
Recruiting
01.04.2025
Sweden Sweden
Recruiting
01.04.2025
The Netherlands The Netherlands
Recruiting
01.04.2025

Trial locations

BMS-986393 is a type of therapy called CAR-T cell therapy. This treatment involves taking some of your own immune cells, changing them in a lab to better fight cancer, and then putting them back into your body. The goal is to help your immune system find and destroy cancer cells more effectively.

Daratumumab is a medication used to treat multiple myeloma, a type of blood cancer. It works by attaching to a specific protein on the surface of cancer cells, helping your immune system to find and kill these cells.

Pomalidomide is a medication that helps your immune system fight cancer. It works by stopping the growth of cancer cells and helping your body’s natural defenses to attack the cancer.

Dexamethasone is a type of steroid that helps reduce inflammation and can also help kill cancer cells. It is often used in combination with other cancer treatments to improve their effectiveness.

Carfilzomib is a medication used to treat multiple myeloma. It works by blocking the action of certain proteins in cancer cells, which can help stop the growth and spread of the cancer.

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 this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of abnormal cells can lead to anemia and increased calcium levels in the blood. The disease often goes through periods of remission and relapse, where symptoms may improve and then worsen again.

Trial ID:
2024-515279-37-00
Protocol code:
CA088-1007
NCT ID:
NCT06615479
Trial Phase:
Therapeutic confirmatory (Phase III)

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