Study Comparing Bortezomib, Lenalidomide, and Dexamethasone with Ciltacabtagene Autoleucel for Newly Diagnosed Multiple Myeloma Patients Not Planning Stem Cell Transplant

3 1 1 1

What is this study about?

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study will explore the effectiveness of different treatment combinations. One group of participants will receive a combination of medications: Bortezomib, Lenalidomide, and Dexamethasone, followed by a special therapy called Ciltacabtagene Autoleucel, which is a type of CAR-T cell therapy. CAR-T cell therapy is a treatment where a patient’s own immune cells are modified to better fight cancer. The other group will receive the same initial combination of Bortezomib, Lenalidomide, and Dexamethasone, followed by continued treatment with Lenalidomide and Dexamethasone.

The purpose of this study is to compare how well these treatment plans work in terms of how long patients live without their disease getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve taking medications in the form of tablets or capsules, and some treatments will be given through an infusion, which means the medicine is delivered directly into the bloodstream through a vein.

Throughout the study, participants will be monitored regularly to assess their health and the effectiveness of the treatments. The study aims to provide valuable information on the best treatment approach for people with newly diagnosed Multiple Myeloma who are not planning to undergo a stem cell transplant as their initial therapy. The trial will continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

1 initial treatment phase

The initial treatment phase involves the administration of a combination of medications: bortezomib, lenalidomide, and dexamethasone. This combination is referred to as VRd therapy.

Bortezomib is administered as a subcutaneous injection. Lenalidomide and dexamethasone are taken orally in the form of capsules and tablets, respectively.

2 treatment group assignment

Participants are randomly assigned to one of two treatment groups after the initial VRd therapy.

One group receives a single administration of ciltacabtagene autoleucel, a type of CAR-T cell therapy, which is given as an intravenous infusion.

The other group continues with maintenance therapy using lenalidomide and dexamethasone, taken orally.

3 maintenance therapy

For participants in the lenalidomide and dexamethasone group, maintenance therapy involves ongoing oral administration of these medications.

The dosage and frequency of lenalidomide and dexamethasone are determined by the study protocol and adjusted based on individual response and tolerance.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

Participants undergo routine medical evaluations, including blood tests and imaging studies, to track the progression of multiple myeloma.

5 end of trial

The trial is estimated to conclude in June 2034. At the end of the trial, data will be analyzed to determine the efficacy of the treatments in terms of progression-free survival.

Participants will receive information about their treatment outcomes and any further steps if necessary.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of Multiple Myeloma, which is a type of blood cancer.
  • Must have a measurable disease at the time of screening, meaning the disease can be measured or tracked by doctors.
  • Must not be considered for high-dose chemotherapy with autologous stem cell transplant (ASCT), which is a procedure where a patient’s own stem cells are used to replace damaged or destroyed bone marrow.
  • Must have an Eastern Cooperative Oncology Group Performance Status grade of 0 or 1, which means the person is fully active or has some symptoms but can carry out light work.
  • If a woman can have children, she must have two negative pregnancy tests before starting the study and agree to more tests during the study.
  • If a woman can have children, she must agree to either not have heterosexual intercourse or use two reliable birth control methods at the same time.
  • If a man is sexually active with a woman who can have children or is pregnant, he must agree to use a barrier method of contraception, like a condom, from the time of signing the consent form until a specified time after the last dose of certain study drugs.
  • Both women and men must agree not to donate eggs or sperm during the study and for a specified time after the last dose of certain study drugs.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have a serious infection that is not under control.
  • Patients who have a history of heart problems, such as a heart attack or heart failure.
  • Patients who have a condition called neuropathy, which means they have nerve damage that causes numbness or tingling, especially if it is severe.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients who are taking part in another clinical trial.
  • Patients who have a known allergy to any of the study drugs.
  • Patients who have a condition called autoimmune disease, where the body’s immune system attacks its own cells.
  • Patients who have a history of drug or alcohol abuse.

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
Centre Hospitalier Universitaire De Poitiers Poitiers France
Region Oestergoetland Linkoping Sweden
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Oulu University Hospital Oulu Finland
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Turku University Hospital Turku Finland
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Rigshospitalet Copenhagen Denmark
University Hospital Ostrava Ostrava Czechia
Ujwkjjammr Mpdkqls Cywose Hlanikcjtwvtfyyne Hamburg Germany
Oxyhnvntbmznvi Liwa Ghwa Linz Austria
Uxvvvimumlpu Mcpnfut Cnvogdx Glzezdbjl Groningen The Netherlands
Htbukgfz Uoefgkwswhyve Mkvnmzu Dd Vmqwqsbvmm Santander Spain
Ileydzms Cnzepq Dmlosfezhffhbrzvo L'hospitalet De Llobregat Spain
Ajqajmxctq Pdldvekt Heylxkbm Db Pasai Paris France
Hjxqjrsx Udgpmrrhar Crkzkoe Hrvlgelc Helsinki Finland
Ewneifo Unvpqbyrgoyg Maddyax Cvtccqb Rfsaiekht (naxeaxp Mah Rotterdam The Netherlands
Apzkrm Ujfzvakeol Hncdaofm Aarhus Denmark
Nujqzibv Idsmnnik Oimtktmxy Idk Mrfqc Snnwvaclbeduglyqbuokcgyrklfr Iqxgnfmt Bhwanmef Cracow Poland
Kulhuqnf dfg Ulpggmcgheyp Miknrjnd Azf Munich Germany
Uxgmcbqwqsanyvbmtxfol Wktbphnpr Ajw Wuerzburg Germany
Ukgnaqkxexmeyz Cvtwwlq Kwwilzntg Gdansk Poland
Hqjzprnq Dh Lp Srovw Cbic I Syhr Pdf Barcelona Spain
Ujxbkmbpcl Ox Ayywbpq Edegem Belgium
Hqaxtcpe Vrjh dxmkxcnv Barcelona Spain
Ubxttoiyor Gpwfbck Hwxtpnkx Ayybxsu 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
19.08.2021
Belgium Belgium
Not recruiting
19.08.2021
Czechia Czechia
Not recruiting
19.08.2021
Denmark Denmark
Not recruiting
19.08.2021
Finland Finland
Not recruiting
19.08.2021
France France
Not recruiting
19.08.2021
Germany Germany
Not recruiting
19.08.2021
Greece Greece
Not recruiting
19.08.2021
Hungary Hungary
Not recruiting
19.08.2021
Ireland Ireland
Not recruiting
19.08.2021
Norway Norway
Not recruiting
19.08.2021
Poland Poland
Not recruiting
19.08.2021
Portugal Portugal
Not recruiting
19.08.2021
Spain Spain
Not recruiting
19.08.2021
Sweden Sweden
Not recruiting
19.08.2021
The Netherlands The Netherlands
Not recruiting
19.08.2021

Trial locations

Bortezomib is a medication used in the treatment of multiple myeloma. It works by interfering with the growth of cancer cells, slowing their spread in the body. In this trial, it is part of the initial treatment combination.

Lenalidomide is another medication used to treat multiple myeloma. It helps the immune system attack cancer cells and also reduces the growth of new blood vessels that tumors need to grow. It is used both in the initial treatment and as part of the maintenance therapy.

Dexamethasone is a type of steroid that helps reduce inflammation and is used to treat multiple myeloma. It is included in both the initial treatment and maintenance therapy in this trial.

Ciltacabtagene Autoleucel is a type of CAR-T cell therapy. This treatment involves modifying a patient’s own T cells to better recognize and attack cancer cells. It is used after the initial treatment in one of the study groups to help control the disease.

In this trial, the combination of these medications and therapies is being studied to determine the best approach for treating newly diagnosed multiple myeloma in patients who are not planning to undergo a stem cell transplant.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause symptoms such as bone pain, fatigue, and frequent infections due to weakened immune function. The abnormal plasma cells can also produce a protein that can damage the kidneys and other organs. Over time, the disease can lead to complications like anemia, kidney problems, and increased risk of fractures.

Trial ID:
2023-505850-16-00
Protocol code:
68284528MMY3004
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    France Norway Spain
  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Norway