Study Comparing Ciltacabtagene Autoleucel with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically looking at patients whose disease has returned after treatment and who are resistant to a medication called Lenalidomide. The trial will compare the effectiveness of a new treatment called JNJ-68284528, also known as a CAR-T cell therapy, against two standard treatment combinations. One combination includes Pomalidomide, Bortezomib, and Dexamethasone (referred to as PVd), and the other includes Daratumumab, Pomalidomide, and Dexamethasone (referred to as DPd).

The purpose of the study is to see how well the new CAR-T cell therapy works compared to the standard treatments. CAR-T cell therapy is a type of treatment where a patient’s own immune cells are modified in a lab to better fight cancer cells. The study will involve participants receiving either the new therapy or one of the standard treatment combinations. The trial will monitor the participants over a period to see which treatment helps in delaying the progression of the disease.

Participants in the study will be randomly assigned to receive either the new CAR-T cell therapy or one of the standard treatment combinations. The study will take place over several months, and participants will be closely monitored by healthcare professionals. The goal is to determine which treatment is more effective in managing relapsed and resistant Multiple Myeloma. This research could potentially lead to new treatment options for patients with this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being at least 18 years old, having a documented diagnosis of multiple myeloma, and having received 1 to 3 prior lines of therapy.

2 randomization

Participants are randomly assigned to one of the treatment groups: either the CAR-T therapy group or one of the standard therapy groups.

The standard therapy groups include either a combination of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

3 treatment administration

For the CAR-T therapy group, the treatment involves cilta-cel, a chimeric antigen receptor T cell therapy directed against BCMA.

For the PVd group, the treatment includes pomalidomide (oral capsules), bortezomib (subcutaneous injection), and dexamethasone (oral tablets).

For the DPd group, the treatment includes daratumumab (subcutaneous injection), pomalidomide (oral capsules), and dexamethasone (oral tablets).

4 monitoring and follow-up

Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes routine health checks and laboratory tests.

Progression-free survival (PFS) is the primary endpoint being measured, which refers to the length of time during and after treatment that the patient lives without the disease worsening.

5 study completion

The study is estimated to conclude by June 2027. Participants will continue to be monitored until the study’s end date or until they meet the criteria for discontinuation.

Who Can Join the Study?

Be at least 18 years old.
Have a confirmed diagnosis of Multiple Myeloma. This is a type of cancer that affects certain blood cells.
Have a measurable disease at the time of screening. This means the disease can be measured or tracked by doctors.
Have received 1 to 3 previous treatments, including a PI (Proteasome Inhibitor) and IMiD (Immunomodulatory Drug). You must have completed at least one full cycle of treatment for each therapy, unless the disease got worse during the treatment.
Have proof that the disease has gotten worse, according to specific criteria, within 6 months of the last treatment.
If you have had only one previous treatment, the disease must have gotten worse within 36 months after a stem cell transplant (a procedure to replace damaged blood cells) or within 42 months of starting the first treatment if no transplant was done.
Be refractory to lenalidomide, meaning the disease did not respond to this drug in at least one previous treatment.
Have an ECOG Performance Status score of 0 or 1. This is a scale used to assess how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Have certain clinical laboratory values as specified in the study protocol.

Who Cannot Join the Study?

Patients who have not experienced a return of their disease after treatment, known as relapsed, or whose disease does not respond to the drug Lenalidomide, referred to as Lenalidomide-Refractory.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specific clinical trial group being studied.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Rigshospitalet	Copenhagen	Denmark
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uuugdlyyyeft Mabdgaq Cjavqkw Gdcsgdrhy	Groningen	The Netherlands
Uhaehoniqx Hntixsxm Coayuda	Cologne	Germany
Achtqpaen Ujn	Amsterdam	The Netherlands
Unwaeat Umkmsvikzc Hfhfgasr	Uppsala	Sweden
Eiugaww Urwcbioctqfx Mmpjywz Ckhjqwm Rxqfvdfad (kuxkcwh Mks	Rotterdam	The Netherlands
Ajdqutw Ooplqbnbqsg Ulymnubhjcvcd Czyjrzcsmror Dazku Sjauad E Djiqa Srdqnyj Df Tjbqtf	Turin	Italy
Ndutcyph Ishchvds Ovjrogyiq Iig Mayil Scgvxxppgktvxlyhtcasdvsbalkk Ihgzfqrm Barfpmdu	Cracow	Poland
Utjwrqbowupxcguhqtxpi Wauttvjkd Abb	Wuerzburg	Germany
Adneuzr Uhfzy Sonhoxvup Lchnvs Dl Bbzuvvy	Bologna	Italy
Uwnaaxkfdvyedx Cduhzcg Ktrowhxrt	Gdansk	Poland
Uvhkxfrgsr Os Acpuoag	Edegem	Belgium
Iuhpflvh Cxtamq Dlqfhiiggjmzotrel	L'hospitalet De Llobregat	Spain
Uxpbfsthjf Gvhzoss Hmbvnjuc Atvwnzq	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.06.2020
Denmark	Not recruiting	30.06.2020
France	Not recruiting	30.06.2020
Germany	Not recruiting	30.06.2020
Greece	Not recruiting	30.06.2020
Italy	Not recruiting	30.06.2020
Poland	Not recruiting	30.06.2020
Spain	Not recruiting	30.06.2020
Sweden	Not recruiting	30.06.2020
The Netherlands	Not recruiting	30.06.2020

Trial locations

Investigated drugs:

JNJ-68284528: This is a type of therapy known as CAR-T cell therapy. It involves modifying a patient’s own T cells to better recognize and attack cancer cells. In this trial, it is directed against a specific protein found on multiple myeloma cells called BCMA. The goal is to help the immune system target and destroy these cancer cells more effectively.

Pomalidomide: This medication is used to treat multiple myeloma by helping the immune system attack cancer cells and by stopping the growth of these cells. It is often used in combination with other drugs to enhance its effectiveness.

Bortezomib: This is a type of medication known as a proteasome inhibitor. It works by interfering with the cancer cells’ ability to break down proteins, which leads to cell death. It is used in combination with other medications to treat multiple myeloma.

Dexamethasone: This is a corticosteroid medication that helps reduce inflammation and suppresses the immune system. In the context of multiple myeloma, it is used to help control the disease and manage symptoms.

Daratumumab: This is a monoclonal antibody that targets a specific protein on the surface of multiple myeloma cells. By binding to this protein, it helps the immune system identify and destroy the cancer cells. It is used in combination with other treatments to improve outcomes for patients with multiple myeloma.

Investigated diseases:

Relapsed and Lenalidomide-Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the disease has returned after treatment (relapsed) and does not respond to the drug lenalidomide (refractory). Multiple myeloma causes cancerous plasma cells to accumulate in the bone marrow, leading to bone damage and affecting the production of healthy blood cells. As the disease progresses, patients may experience symptoms such as bone pain, fatigue, and frequent infections. The condition is characterized by cycles of remission and relapse, with each relapse potentially being more challenging to treat.

Trial ID:

2023-506588-32-00

Protocol code:

68284528MMY3002

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ciltacabtagene Autoleucel with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?