Study on Monitoring Untreated Multiple Myeloma in Patients Using Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone or a New Drug Combination

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What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves a treatment combination that includes Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone, known as D-VRd. Some participants will also receive a stem cell transplant, while others will receive additional treatment with Teclistamab and Talquetamab, which are newer therapies being explored for their effectiveness.

The purpose of the study is to use new methods to monitor the disease and understand how well these treatments work in patients who have not yet received any treatment for their multiple myeloma. Participants will receive the treatment over a period of time, and their response to the treatment will be closely monitored using advanced techniques to measure the presence of cancer cells in the blood and bone marrow. This will help researchers understand the effectiveness of the treatment combinations and the potential for achieving a state where no cancer cells are detectable.

The study will take place over several months, with regular check-ups and assessments to track the progress of the disease and the patient’s response to the treatment. The goal is to gather information that could lead to better treatment strategies for multiple myeloma in the future. Participants will be monitored for any side effects or changes in their condition throughout the study period.

1 initial treatment phase

Begin treatment with a combination of medications including daratumumab, bortezomib, lenalidomide, and dexamethasone. These medications are administered to manage multiple myeloma.

Daratumumab is given as a subcutaneous injection. Bortezomib is also administered via subcutaneous injection. Lenalidomide and dexamethasone are taken orally in capsule form.

2 stem cell transplantation or alternative therapy

For those eligible, an autologous stem cell transplantation (ASCT) may be performed. This involves using your own stem cells to help restore bone marrow function after high-dose chemotherapy.

Alternatively, continue with the same combination of medications or switch to a new combination involving teclistamab and talquetamab if not undergoing transplantation.

3 consolidation therapy

Following transplantation or alternative therapy, continue with the initial combination of medications to consolidate the treatment effects.

This phase aims to further reduce the number of cancer cells and stabilize the disease.

4 monitoring and follow-up

Regular monitoring of minimal residual disease (MRD) is conducted using advanced techniques to assess the effectiveness of the treatment.

MRD measurements are taken from bone marrow and peripheral blood to evaluate the presence of cancer cells.

5 completion of treatment

The treatment course is completed after the specified number of cycles, which may vary depending on the treatment plan and response.

Ongoing assessments will determine the overall response and any further treatment needs.

Who Can Join the Study?

Age between 18 and 70 years old.
Must have a new diagnosis of Multiple Myeloma (MM) according to specific criteria.
Must have measurable disease, which means certain levels of specific proteins in the blood or urine.
Must be newly diagnosed and not have received treatment before, with a plan to undergo high-dose therapy and a procedure called autologous stem cell transplantation.
Must have a performance status score of 0, 1, or 2, which is a way to measure how well a person can perform daily activities.
Must have certain laboratory values that show adequate function of the bone marrow, liver, and kidneys. This includes:
- Hemoglobin level of at least 7.5 g/dL without recent blood transfusion.
- Absolute neutrophil count (ANC) of at least 1.0 x 10⁹/L.
- Platelet count of at least 50 x 10⁹/L if the bone marrow is heavily involved, otherwise at least 75 x 10⁹/L.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no more than 2.5 times the upper limit of normal.
- Total bilirubin level no more than 1.5 times the upper limit of normal, except in certain conditions.
- Estimated creatinine clearance of at least 30 mL/min, which is a measure of kidney function.
- Corrected serum calcium level no more than 13.5 mg/dL or free ionized calcium no more than 6.5 mg/dL.

Who Cannot Join the Study?

Patients who have a different condition than Multiple Myeloma cannot participate.
Patients who are not eligible for a transplant cannot participate.
Patients who have not been treated with the specific therapies mentioned in the study cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not male or female cannot participate.
Patients who are considered part of a vulnerable population 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
Medical University Of Vienna	Vienna	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Rimini	Italy
Alexandra Hospital	Athens	Greece
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Amphia Hospital	Breda	The Netherlands
Universita Degli Studi Di Brescia	Brescia	Italy
Saint Savvas Oncology Hospital	Athens	Greece
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Dijklander Ziekenhuis	Hoorn	The Netherlands
Awgqszjxj Ulm	Amsterdam	The Netherlands
Ajikfat Uky Iqatz Dc Rlielc Ewrqhp	Reggio Emilia	Italy
Unoiabuxrb Mubqqhp Ceihsg Hlyfhqljvborryhxa	Hamburg	Germany
Tkfiazdyeq Cdkeis Hwkgipvf	Thessaloniki	Greece
Aoyskbi Omerlmauers Ujxqaiiolciwk Chtullbpanuo Dvobv Sqqcmr E Dvsqo Smzwanr Du Tycmaj	Turin	Italy
Apjebkl Uofaa Swtrhjrqm Lauedx Dr Bcifxwt	Bologna	Italy
Aosnarn Oshjzsqyjyr Pzqv Gabkonqj Xwocl	Bergamo	Italy
Oncwapblfxubue Lgys Gcjr	Linz	Austria
Rsexdsqko Zbyibhjbph Sxjdtyvmn	Arnhem	The Netherlands
Ucwkqrxvsiyy Mbcurda Cfbexbz Ggpxxeeci	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.10.2023
Germany	Recruiting	01.10.2023
Greece	Recruiting	01.10.2023
Italy	Recruiting	01.10.2023
The Netherlands	Recruiting	01.10.2023

Trial locations

Investigated drugs:

Daratumumab is a medication used to treat multiple myeloma. It works by targeting a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells.

Bortezomib is a medication that helps treat multiple myeloma by interfering with the growth of cancer cells. It works by blocking a certain protein that cancer cells need to grow and multiply.

Lenalidomide is a medication used in the treatment of multiple myeloma. It helps the immune system attack cancer cells and also stops the growth of new blood vessels that tumors need to grow.

Dexamethasone is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it helps to enhance the effects of other cancer treatments.

Teclistamab is an investigational medication being studied for its potential to treat multiple myeloma. It is designed to help the immune system recognize and attack myeloma cells.

Talquetamab is another investigational medication being tested for the treatment of multiple myeloma. It aims to target specific proteins on myeloma cells, helping the immune system to destroy them.

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 crowd out healthy blood cells, leading to problems such as anemia, infections, and bone damage. As the disease progresses, it can cause bone pain, fractures, and high levels of calcium in the blood. Patients may also experience kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. Over time, the disease can lead to weakened bones and increased susceptibility to infections. The progression of Multiple Myeloma varies among individuals, with some experiencing slow development and others facing more rapid advancement.

Trial ID:

2023-505221-14-00

Protocol code:

EMN33

NCT ID:

NCT06189833

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Monitoring Untreated Multiple Myeloma in Patients Using Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone or a New Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?