Study Comparing Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone with Ciltacabtagene Autoleucel or Stem Cell Transplant for Newly Diagnosed Multiple Myeloma Patients

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What is this study about?

This clinical trial is focused on studying treatments for Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will compare two treatment approaches for patients who are newly diagnosed and eligible for a stem cell transplant. The first approach involves a combination of medications: Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (referred to as DVRd), followed by a treatment called Ciltacabtagene Autoleucel, which is a type of cell therapy. The second approach uses the same combination of medications (DVRd) followed by an Autologous Stem Cell Transplant (ASCT), where a patient’s own stem cells are used to help restore healthy bone marrow.

The purpose of the study is to compare the effectiveness of these two treatment strategies. Participants will receive either the DVRd treatment followed by Ciltacabtagene Autoleucel or the DVRd treatment followed by ASCT. The study will monitor the progress of the disease and the response to treatment over time. Participants will be closely observed to see how well the treatments work in controlling the disease and maintaining remission, which means the cancer is not active.

Throughout the study, participants will receive regular medical check-ups and assessments to ensure their safety and to track the effectiveness of the treatments. The study aims to provide valuable information on which treatment approach may offer better outcomes for patients with newly diagnosed Multiple Myeloma. Participants will be randomly assigned to one of the two treatment groups, and some may receive a placebo as part of the study design. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being studied.

1 initial treatment phase

The initial treatment phase involves the administration of a combination of medications. These include daratumumab, bortezomib, lenalidomide, and dexamethasone.

Daratumumab is given as a solution for injection under the skin. Bortezomib is also administered as a solution for injection.

Lenalidomide is provided in capsule form and taken orally. Dexamethasone is available in tablet form and is also taken orally.

2 treatment continuation

The treatment continues with the same combination of medications: daratumumab, bortezomib, lenalidomide, and dexamethasone.

The administration routes and forms remain the same as in the initial phase.

3 treatment comparison

Participants are divided into two groups for comparison. One group receives ciltacabtagene autoleucel, a dispersion for infusion administered intravenously.

The other group undergoes an autologous stem cell transplant (ASCT), which involves using the participant’s own stem cells.

4 consolidation phase

Following the comparison phase, participants continue with lenalidomide therapy.

This phase aims to consolidate the treatment effects and is crucial for long-term outcomes.

5 follow-up and monitoring

Participants are monitored for progression-free survival (PFS) and sustained minimal residual disease (MRD)-negative complete response (CR).

Regular assessments are conducted to evaluate the overall response and any adverse effects.

Who Can Join the Study?

  • Must be 18 years of age or older.
  • Must have a confirmed diagnosis of Newly Diagnosed Multiple Myeloma (NDMM), which is a type of blood cancer, according to specific medical guidelines.
  • High-dose therapy and Autologous Stem Cell Transplant (ASCT) should be part of the planned initial treatment. ASCT is a procedure where a patient’s own stem cells are used to replace damaged or destroyed bone marrow.
  • Must have a measurable disease, which means the disease can be measured by certain tests. This includes having a specific level of a protein in the blood or urine, or a certain level of free light chains in the blood, which are parts of antibodies.
  • Must have an ECOG performance status of grade 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must have certain clinical laboratory values within a specified range, as detailed in the study protocol.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range for this study is typically adults.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are usually those that could make the study unsafe for the patient.
  • Patients who are pregnant or breastfeeding cannot participate, as the study treatments might affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients who have had certain treatments for Multiple Myeloma before may not be eligible to participate.
  • Patients who have allergies to any of the study medications 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
Oncopole Claudius Regaud Toulouse France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Poitiers Poitiers France
Region Oestergoetland Linkoping Sweden
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University Of Skane Malmo Sweden
Hospital Universitario Ramon Y Cajal Madrid Spain
Fakultni Nemocnice Plzen Plzen Czechia
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
University Hospital Ostrava Ostrava Czechia
Universitaetsklinikum Leipzig AöR Leipzig Germany
Uxivfmrknk Mdkyehu Cevdai Hmhuszrdazdhjiosy Hamburg Germany
Uwadalejkcvs Meicdzr Cbkrpul Gfvlswxtp Groningen The Netherlands
Ikowfxyp Ceordt Dtfiygweshdzddtwz L'hospitalet De Llobregat Spain
Uqupotcysw Hgiowlcc Clvatpy Cologne Germany
Apaoqgdeg Ugu Amsterdam The Netherlands
Auyktfqmnz Pegcxqyr Hvvbuoii Du Pagwj Paris France
Uinvvmg Untdhsqclf Hqdvkwms Uppsala Sweden
Sapkkjtjz Rzzxrzc Uifslkpivf Morowyq Cozane Nijmegen The Netherlands
Eefthce Uyivuiwaxvem Mbfskyi Cettoop Rdefmkgqp (sdkzwgd Mkd Rotterdam The Netherlands
Ujryvzdoqwqoxpcmkvazm Wmkaaicfb Aos Wuerzburg Germany
Ucidvgrizl Of Aahkkqe Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.09.2022
Czechia Czechia
Recruiting
01.09.2022
France France
Recruiting
01.09.2022
Germany Germany
Recruiting
01.09.2022
Greece Greece
Recruiting
01.09.2022
Norway Norway
Recruiting
01.09.2022
Spain Spain
Recruiting
01.09.2022
Sweden Sweden
Recruiting
01.09.2022
The Netherlands The Netherlands
Recruiting
01.09.2022

Trial locations

Daratumumab is a medication used to treat multiple myeloma, a type of blood cancer. It works by helping the immune system to identify and destroy cancer cells.

Bortezomib is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body. It is used to treat multiple myeloma.

Lenalidomide is a medication that affects the immune system. It promotes immune responses to help slow down the growth of cancer cells. It is used in the treatment of multiple myeloma.

Dexamethasone is a type of steroid that helps reduce inflammation and is used in combination with other medications to treat multiple myeloma.

Ciltacabtagene Autoleucel is a type of gene therapy used in the treatment of multiple myeloma. It involves modifying a patient’s own immune cells to better recognize and attack cancer cells.

Autologous Stem Cell Transplant (ASCT) is a procedure in which a patient’s own stem cells are collected, stored, and then given back to the patient after intensive treatment. This helps to restore the bone marrow and immune system.

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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.

Trial ID:
2023-507632-20-00
Protocol code:
EMN2868284528MMY3005
NCT ID:
NCT05257083
Trial Phase:
Therapeutic confirmatory (Phase III)

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