Study Comparing Daratumumab with Drug Combination for Young Patients with Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplantation

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What is this study about?

This clinical trial is focused on studying treatments for multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves young patients who have been newly diagnosed with this condition and are eligible for a procedure called autologous stem cell transplantation, which uses the patient’s own stem cells to help restore healthy bone marrow. The trial aims to compare two different treatment combinations before and after the transplantation. One group will receive a combination of daratumumab, bortezomib, cyclophosphamide, and dexamethasone (referred to as Dara-VCd), while the other group will receive bortezomib, thalidomide, and dexamethasone (referred to as VTd). After the transplantation, both groups will undergo a maintenance phase with ixazomib, either alone or combined with daratumumab.

The purpose of the study is to determine how well these treatments work in preventing the progression of multiple myeloma over a period of time. The study will also look at how many patients achieve a state called minimal residual disease negativity, which means that very few cancer cells are left in the body after treatment. This will be assessed using a method called next generation sequencing, which is a way to analyze genetic material in detail. The trial will last for several years, with regular assessments to monitor the effectiveness of the treatments.

Participants in the study will receive their treatments either orally or through injections, depending on the specific medication. The trial is designed to provide valuable information on the best treatment strategies for young patients with multiple myeloma, helping to improve outcomes and quality of life. The study is conducted in multiple centers, allowing for a comprehensive evaluation of the treatments across different patient populations.

1 induction phase

During the induction phase, two treatment options are available: daratumumab combined with bortezomib, cyclophosphamide, and dexamethasone (Dara-VCd) or the combination of bortezomib, thalidomide, and dexamethasone (VTd).

Daratumumab is administered as a subcutaneous injection. Bortezomib is given as a subcutaneous injection. Cyclophosphamide is taken orally. Dexamethasone is taken orally.

Thalidomide is taken orally. The duration of this phase is determined by the study protocol.

2 transplantation

Following the induction phase, eligible patients undergo an autologous stem cell transplantation. This involves collecting the patient’s own stem cells, which are then reintroduced after high-dose chemotherapy.

3 consolidation phase

After transplantation, the consolidation phase begins. Patients continue with the same treatment regimen as in the induction phase to strengthen the response to treatment.

The duration of this phase is specified in the study protocol.

4 maintenance phase

In the maintenance phase, patients receive ixazomib alone or in combination with daratumumab to maintain the treatment response.

Ixazomib is taken orally. The duration of this phase is determined by the study protocol.

Who Can Join the Study?

Patient must be between 18 and 65 years old.
Women who can have children must agree to use two reliable birth control methods or abstain from heterosexual intercourse. This includes one highly effective method like birth control pills or an intrauterine device, and one additional method like a condom. This must start before taking the study drugs and continue for a specific time after the last dose.
Men must agree to use a condom or abstain from sex during the study and for a specific time after the last dose of study drugs.
Patient must have a certain level of physical activity, measured by a score called ECOG or Karnofsky performance status.
Patient must have certain blood test results within 30 days before joining the study, including:
- Platelet count of at least 75 x 10⁹ per liter.
- Absolute neutrophil count (ANC) of at least 1 x 10⁹ per liter.
- Corrected serum calcium less than 14 mg/dL.
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels not more than 2.5 times the normal limit.
- Total bilirubin not more than 1.5 times the normal limit.
- Creatinine clearance of at least 30 mL per minute.
Patient must have a life expectancy of more than 3 months.
Patient must be eligible for a procedure called ASCT, which involves using their own stem cells.
Patient must have a heart function measurement called LVEF of at least 40%, checked by a test called an echocardiogram or MUGA scan.
Patient must be newly diagnosed with multiple myeloma.
Patient must provide written consent to participate in the study, understanding they can withdraw at any time.
Patient must have documented multiple myeloma with measurable disease, which means:
- Monoclonal plasma cells in the bone marrow of at least 10% or a biopsy-proven plasmacytoma.
- Measurable disease with specific protein levels in the blood or urine.
Patient must show evidence of organ damage or specific markers of cancer, such as:
- High calcium levels in the blood.
- Kidney problems with low creatinine clearance or high serum creatinine.
- Low hemoglobin levels indicating anemia.
- Bone lesions visible on imaging tests.
Patient must have one or more specific markers of cancer, such as:
- High percentage of clonal plasma cells in the bone marrow.
- Abnormal serum free light chain ratio.
- More than one focal lesion on MRI studies.
Patient must be willing and able to follow the study requirements, according to the investigator’s opinion.

Who Cannot Join the Study?

Patients who are not diagnosed with Multiple Myeloma (MM), a type of blood cancer.
Patients who are not eligible for the autologous transmission of stem cells, which is a procedure where a patient’s own stem cells are collected and then given back to them after treatment.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements, as the study includes both male and female participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Fakultni Nemocnice Plzen	Plzen	Czechia
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alexandra Hospital	Athens	Greece
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
General University Hospital Of Patras	Patras	Greece
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Universita Degli Studi Di Brescia	Brescia	Italy
University Hospital Ostrava	Ostrava	Czechia
Atmlltg Oycgnjpkdex Ubqkrtdujnaxz Caqhyrriaoto Dfmoo Spimsr E Daini Srytbmj Db Twzjwt	Turin	Italy
Anbhaik Uxs Iuinf Dn Rjegep Enlitn	Reggio Emilia	Italy
Aghizpk Uozyj Scwguilhd Lrcrfo Dj Bmnthpk	Bologna	Italy
Apedhwo Otbiwoxkeuk Pzrq Ghmcrsho Xevdf	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	16.04.2019
Greece	Not recruiting	16.04.2019
Italy	Not recruiting	16.04.2019

Trial locations

Investigated drugs:

Daratumumab is a medication used in this trial to treat multiple myeloma. It is an antibody that helps the immune system to find and destroy cancer cells. In this study, it is combined with other drugs to enhance its effectiveness in treating the disease.

Bortezomib is a drug that interferes with the growth of cancer cells and slows their spread in the body. It is used in combination with other medications in this trial to treat multiple myeloma.

Cyclophosphamide is a chemotherapy medication that works by slowing or stopping the growth of cancer cells. It is used in this study as part of a combination treatment for multiple myeloma.

Dexamethasone is a type of steroid that helps reduce inflammation and is used to treat various conditions, including cancer. In this trial, it is used alongside other medications to help treat multiple myeloma.

Thalidomide is a medication that helps to slow the growth of cancer cells and is used in combination with other drugs in this trial to treat multiple myeloma.

Ixazomib is a medication that helps to stop the growth of cancer cells. In this study, it is used during the maintenance phase to help keep the cancer from returning after initial treatment.

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. 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, patients may experience symptoms such as bone pain, fatigue, frequent infections, and anemia. The accumulation of myeloma cells in the bone marrow can also lead to bone lesions and fractures. Over time, the disease can cause significant organ damage and impair the body’s ability to produce healthy blood cells.

Trial ID:

2024-511781-37-00

Protocol code:

EMN18

NCT ID:

NCT03896737

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Daratumumab with Drug Combination for Young Patients with Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?