Study Comparing Idecabtagene Vicleucel and Lenalidomide Maintenance Therapy for Adults with Newly Diagnosed Multiple Myeloma After Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying the treatment of Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves adult participants who have been newly diagnosed with this condition and have not responded optimally after undergoing a procedure called Autologous Stem Cell Transplantation (ASCT). The trial aims to compare the effectiveness and safety of a new treatment called Idecabtagene Vicleucel (also known as bb2121) combined with Lenalidomide maintenance therapy, against Lenalidomide maintenance therapy alone. Lenalidomide is a medication that helps to slow down or stop the growth of cancer cells, while Idecabtagene Vicleucel is a type of cell therapy that uses modified immune cells to target and destroy cancer cells.

Participants in the study will receive either the combination of Idecabtagene Vicleucel and Lenalidomide or Lenalidomide alone. The study will monitor the participants over a period to assess how well the treatments work in preventing the progression of the disease, which is referred to as Progression Free Survival (PFS). The trial will also look at other outcomes such as overall survival, the duration of response to the treatment, and any side effects experienced by the participants. The study is designed to provide valuable information on whether the combination therapy offers better outcomes compared to Lenalidomide alone.

The trial will involve regular check-ups and assessments to monitor the participants’ health and response to the treatment. Participants will receive the treatments through different methods, such as oral capsules for Lenalidomide and intravenous infusions for Idecabtagene Vicleucel. The study is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments. This research is crucial in finding more effective ways to manage and treat Multiple Myeloma, especially for those who do not achieve the desired response from standard treatments.

1 joining the study

Upon joining the study, the participant is confirmed to have a newly diagnosed condition known as multiple myeloma with a suboptimal response after a procedure called autologous stem cell transplantation.

2 initial treatment phase

The participant receives a combination of medications including lenalidomide in the form of hard capsules, taken orally. The dosage may vary between 2.5 mg, 5 mg, 10 mg, and 15 mg depending on the specific treatment plan.

Other medications administered include cyclophosphamide monohydrate and fludarabine phosphate, both given through intravenous infusion. These medications are used to prepare the body for the main treatment.

3 main treatment phase

The main treatment involves the administration of idecabtagene vicleucel, a specialized therapy given through intravenous infusion. This is a key part of the study aimed at improving the participant’s condition.

Supportive medications such as diphenhydramine hydrochloride and paracetamol may be given orally to manage any side effects and ensure comfort during the treatment.

4 maintenance therapy

Following the main treatment, the participant continues with lenalidomide maintenance therapy. This involves taking the medication in capsule form orally, with the dosage adjusted as needed to maintain the participant’s health and prevent disease progression.

5 monitoring and follow-up

Throughout the study, the participant’s health is closely monitored. Regular assessments are conducted to evaluate the effectiveness of the treatment and to check for any adverse effects.

The study aims to measure outcomes such as progression-free survival and other health indicators to determine the success of the treatment.

Who Can Join the Study?

  • Participants must be 18 years or older with Newly Diagnosed Multiple Myeloma who have received treatment including high-dose chemotherapy and autologous stem cell transplantation (a procedure where a patient’s own stem cells are used to replace damaged or destroyed bone marrow).
  • Participants should not have received further treatment after the stem cell transplantation, except for a short period (7 days or less) of lenalidomide (a medication used to treat multiple myeloma) if it does not affect the overall benefit or risk.
  • Participants must have completed 4 to 6 cycles of initial therapy that includes at least an immunomodulatory drug (a drug that helps regulate the immune system) and a proteasome inhibitor (a drug that blocks the action of proteasomes, which are protein complexes that break down proteins) and possibly an anti-CD38 monoclonal antibody (a type of drug that targets specific proteins on cancer cells). They must have had a single stem cell transplant 80 to 120 days before joining the study.
  • Participants must not have shown confirmed progression of the disease since starting the initial therapy.
  • Participants must have a documented response of Partial Response (PR) or Very Good Partial Response (VGPR) at the time of joining the study. These terms refer to the level of improvement in the disease.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities. A score of 1 means the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature.
  • Participants with an ECOG score of 2 due to pain from myeloma-related bone lesions may still be eligible if the investigator agrees.
  • Participants must have recovered to a level of 1 or less for any non-blood-related side effects from previous treatments, except for hair loss and moderate nerve damage.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Newly Diagnosed Multiple Myeloma with a suboptimal response after an Autologous Stem Cell Transplantation. This means the patient must have this specific type of blood cancer and have had a transplant using their own stem cells, but the treatment did not work as well as expected.
  • Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study may involve medications that could affect the baby.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of 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
Technische Universitaet Dresden Dresden Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
General University Hospital Of Patras Patras Greece
Assistance Publique Hopitaux De Paris Paris France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Evangelismos S.A. Athens Greece
Institut Jules Bordet Anderlecht Belgium
Institutul Regional De Oncologie Iasi Iasi Romania
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Vrije Universiteit Brussel Jette Belgium
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Odense University Hospital Odense Denmark
Universitaetsklinikum Leipzig AöR Leipzig Germany
Fundeni Clinical Institute Bucharest Romania
Cibpkuyal Ufvsktivyilftq Suubzlshs Woluwe-Saint-Lambert Belgium
Aimteldwnh Pchbuiko Hkzsityt Dj Pxigo Paris France
Uvmlrtbzpd Mzbpply Crtftd Htpixjfbscygeecwh Hamburg Germany
Ufipyqsmwbfenjzfqhnxs Eonni Alg Essen Germany
Ulgjoocime Hilwmttm Cngfulq Cologne Germany
Altzyop Ocoqbxvaygb Utlulrsuyqihi Clafyilwkpab Dyhqx Sovifj E Dqxyy Smdprrl Df Thpdee Turin Italy
Udriqlmswkoxicdsbkskl Wyyzkxpld Akn Wuerzburg Germany
Azuutyb Ualnm Sorkgvanj Llwvzz Dq Blavthh Bologna Italy
Udeappudmwzeir Ctzfepn Kwzqjtwxr Gdansk Poland
Ubcioeepyl Diokd Sdafk Di Rdvx Lb Scjilwym Rome Italy
Iavmdtuj Cdblvu Dglgciyxhlwwgyrvc L'hospitalet De Llobregat Spain
Hvczijcz Ujuiegahbcbyg Heuaoxuy Tcwkq y Pabeto Ideypvmb Cwcelh dupckmqvrxwiqpndb (gtbe Badalona Spain
Hbnfilv Hbsbn Mxwsdr &wbfsni 1 rrw Gwzmxsn Exxdch Creteil France
Iddhgfwh Pjxhggceexujfao Cfcfnj Ctdacb Marseille France
Uplovvalpp Grwfxwd Hjgvarzm Aazucav 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
27.07.2023
Belgium Belgium
Not recruiting
27.07.2023
Czechia Czechia
Not recruiting
27.07.2023
Denmark Denmark
Not recruiting
27.07.2023
France France
Not recruiting
27.07.2023
Germany Germany
Not recruiting
27.07.2023
Greece Greece
Not recruiting
27.07.2023
Italy Italy
Not recruiting
27.07.2023
Norway Norway
Not recruiting
27.07.2023
Poland Poland
Not recruiting
27.07.2023
Romania Romania
Not recruiting
27.07.2023
Spain Spain
Not recruiting
27.07.2023

Trial locations

Idecabtagene Vicleucel is a type of therapy that uses genetically modified cells to target and destroy cancer cells. It is specifically designed to treat multiple myeloma, a type of blood cancer. This therapy involves collecting a patient’s own immune cells, modifying them in a laboratory to better recognize and attack cancer cells, and then infusing them back into the patient.

Lenalidomide is a medication used to treat multiple myeloma. It works by helping the immune system attack cancer cells and by stopping the growth of new blood vessels that tumors need to grow. In this trial, Lenalidomide is used as a maintenance therapy to help prevent the cancer from returning after initial treatment.

Investigated diseases:

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 bone damage, kidney problems, and a weakened immune system. The disease often progresses slowly, with symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of these abnormal cells can cause anemia and other blood-related issues. The progression of Multiple Myeloma can vary, with periods of stability followed by more aggressive phases. It is considered a chronic condition that requires ongoing monitoring and management.

Trial ID:
2022-501346-30-00
Protocol code:
CA089-1043
Trial Phase:
Therapeutic confirmatory (Phase III)

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