Study Comparing Teclistamab with Daratumumab, Pomalidomide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition known as Relapsed or Refractory Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study aims to compare the effectiveness of different treatment combinations for this condition. One group of participants will receive a combination of Teclistamab and Daratumumab (referred to as Tec-Dara), while another group will receive a combination of Daratumumab, Pomalidomide, and Dexamethasone (referred to as DPd). A third group will receive Daratumumab, Bortezomib, and Dexamethasone (referred to as DVd). Daratumumab and Teclistamab are given as injections under the skin, while Pomalidomide, Dexamethasone, and Bortezomib are taken orally in capsule or tablet form.

The purpose of the study is to compare the effectiveness of these treatment combinations in managing the disease. Participants will be randomly assigned to one of the treatment groups and will receive their respective treatments over a specified period. The study will monitor the participants’ health and response to the treatments to gather data on how well each combination works. This will help in understanding which treatment option might be more beneficial for patients with this type of multiple myeloma.

Throughout the study, participants will undergo regular health check-ups and assessments to ensure their safety and to track the progress of their condition. The study is designed to provide valuable insights into the treatment of Relapsed or Refractory Multiple Myeloma and aims to improve the options available for managing this challenging condition.

1 initial treatment phase

Upon joining the study, the treatment begins with the administration of teclistamab and daratumumab. Both medications are given as a solution for injection under the skin (subcutaneous use).

The frequency and dosage of these medications will be determined by the study protocol and the healthcare team overseeing the trial.

2 combination therapy phase

Depending on the assigned group, additional medications may be introduced. These include pomalidomide and dexamethasone, which are taken orally in the form of capsules or tablets.

Alternatively, bortezomib may be administered as a subcutaneous injection, combined with dexamethasone tablets.

3 monitoring and assessment

Throughout the trial, regular monitoring of health status and response to treatment is conducted. This includes blood tests and other assessments to evaluate the effectiveness of the treatment.

Adjustments to medication dosages or schedules may occur based on these assessments.

4 end of treatment phase

The treatment phase continues until the study’s end date or until specific criteria for discontinuation are met, such as disease progression or unacceptable side effects.

Upon completion, a final evaluation is conducted to assess the overall response to the treatment.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer, according to specific medical guidelines.
  • The patient must have a measurable level of disease at the start of the study, which can be shown by certain levels of proteins in the blood or urine.
  • The patient must have received 1 to 3 previous treatments for multiple myeloma, including a type of drug called a proteasome inhibitor and another drug called lenalidomide. If the patient has only had one previous treatment, they must not have responded well to lenalidomide.
  • The patient must show signs that their disease is getting worse, as determined by a doctor using specific criteria.
  • The patient must have a performance status score of 0, 1, or 2, which is a way to measure how well they can perform daily activities.
  • The patient must have certain laboratory test results within a specified range to ensure they are healthy enough to participate.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable, meaning they might need extra care or protection.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Relapsed/Refractory Multiple Myeloma cannot participate. This means the study is only for those with this specific condition.
  • Patients who are not within the specified age range cannot participate. The study is for adults, so children and very elderly individuals may not be eligible.
  • Patients who are unable to provide informed consent cannot participate. This means they must be able to understand the study and agree to take part.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients with certain other health conditions that might interfere with the study cannot participate. This is to ensure accurate results and the safety of the participants.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the results of this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Region Vaesterbotten Umea Sweden
Universitair Ziekenhuis Gent Gent Belgium
Isala Klinieken Stichting Zwolle The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Region Skane Helsingborg Hospital Helsingborg Sweden
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Region Dalarna Falun Sweden
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Pratia Hematologia Sp. z o.o. Katowice Poland
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
St. Barbara-Klinik Hamm GmbH Hamm Germany
Aalborg University Hospital Aalborg Denmark
Gasthuiszusters Antwerpen Antwerp Belgium
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Rigshospitalet Copenhagen Denmark
CHU Helora La Louviere Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Universitaetsklinikum Leipzig AöR Leipzig Germany
Uoequtfdtx Mwuayfb Cmquoi Hbhmssxfbjfsmzhdg Hamburg Germany
Uxtjkwmdlswj Mgzflbl Cmqlhpc Glajlcdid Groningen The Netherlands
Hqspfvhl Uptsxscehjfaw Mblsnfp Db Vgsrnelapt Santander Spain
Ignyktiy Cijigg Drbmcfdfhxcrvagua L'hospitalet De Llobregat Spain
Tkncyeajov Cdrjxc Hdrdrpie Thessaloniki Greece
Csdxkh Hzhgfdoexdi Ei Uwamdgyrojjrw Db Lbzcqdv Limoges France
Irunylxe Rolzgcwvp Pbb Lz Sfogcr Dlq Tsphhm Dror Aesrqwh Ivfw Shhhkl Meldola Italy
Azbpibqtg Ulk Amsterdam The Netherlands
Udwdvph Usqmnztpil Hjluqwxd Uppsala Sweden
Uqpbjskiqqhzorpbxzitg Darxtdbekcn Amn Duesseldorf Germany
Adfbym Umvfekiakg Hxawgyoh Aarhus Denmark
Ccrdac Hrxwydjwsrj Rrboyurc Uwesiclhvgqiq Dv Tetjh Tours France
Arkrrrh Oqjllnjezbt Urpxfcfffhrih Cvvesraxzgkl Dvuuw Stuhcd E Drami Sgzrwqe Dv Teyfhs Turin Italy
Nsxhuwkl Itlqllyw Odnptoheq Ijj Menlr Srukvdxoifcytiheghvpyapgmpho Ixvbvzea Bezhfuus Cracow Poland
Awdhiof Upqiw Sosfknurv Lixrcf Dn Bycehuz Bologna Italy
Ulrgohfiloyfpe Cyaqxlw Kgbgwjbqf Gdansk Poland
Abvfvlt Ojuuhrvsbjc Pzxu Guqehxgq Xzxjq Bergamo Italy
Hrknflmv Vigd dirdianr Barcelona Spain
Hkevxmxx Ulrhlrvtzbwjec Suhapmzech &mhdumk Hdmqrlb dm Hyjvlklabug STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
25.10.2021
Denmark Denmark
Not recruiting
25.10.2021
France France
Not recruiting
25.10.2021
Germany Germany
Not recruiting
25.10.2021
Greece Greece
Not recruiting
25.10.2021
Italy Italy
Not recruiting
25.10.2021
Poland Poland
Not recruiting
25.10.2021
Spain Spain
Not recruiting
25.10.2021
Sweden Sweden
Not recruiting
25.10.2021
The Netherlands The Netherlands
Not recruiting
25.10.2021

Trial locations

Teclistamab is an investigational medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is being tested in combination with other treatments to see if it can help improve outcomes for patients whose cancer has returned or is not responding to previous treatments.

Daratumumab SC is a medication used to treat multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to destroy them. In this study, it is being used both alone and in combination with other drugs to evaluate its effectiveness.

Pomalidomide is a medication that helps the immune system fight cancer and is used to treat multiple myeloma. It is often used when other treatments have not been successful. In this trial, it is combined with other medications to assess its impact on the disease.

Dexamethasone is a type of steroid that is used to reduce inflammation and suppress the immune system. It is commonly used in combination with other cancer treatments to help manage multiple myeloma and improve patient outcomes.

Bortezomib is a medication that interferes with the growth of cancer cells and is used to treat multiple myeloma. It is being tested in combination with other drugs in this study to determine its effectiveness in treating patients with relapsed or refractory multiple myeloma.

Relapsed/Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement. In refractory multiple myeloma, the disease does not respond to treatment or stops responding after a while. The progression of this disease involves the accumulation of abnormal plasma cells in the bone marrow, leading to bone damage, anemia, kidney dysfunction, and increased risk of infections. Over time, the disease can cause significant damage to bones and organs due to the overproduction of these abnormal cells. Symptoms may include bone pain, fatigue, frequent infections, and high calcium levels in the blood.

Trial ID:
2023-503441-55-00
Protocol code:
64007957MMY3001
Trial Phase:
Therapeutic exploratory (Phase II)

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