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Study Comparing Teclistamab with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma After 1-3 Prior Treatments

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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 aims to compare the effectiveness of a new treatment called teclistamab with other existing treatments. These existing treatments include combinations of medications such as pomalidomide, bortezomib, and dexamethasone, as well as carfilzomib and dexamethasone. Pomalidomide is also known by its code name CC-4047, and carfilzomib is sometimes referred to as PR-171. The study will also involve a placebo group for comparison.

The purpose of the study is to determine which treatment is more effective for patients with relapsed or refractory multiple myeloma, meaning the cancer has returned or is not responding to previous treatments. Participants in the study will receive one of the treatments mentioned above, and their progress will be monitored over time. The study will help researchers understand how well these treatments work in managing the disease and improving patient outcomes.

Participants will be randomly assigned to receive either the new treatment or one of the existing treatment combinations. The study will take place over a period of time, during which participants will be regularly assessed to track their response to the treatment. The main goal is to see how long patients can live without the disease getting worse, known as progression-free survival. This study is an important step in finding better ways to treat multiple myeloma and improve the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of multiple myeloma and ensuring previous treatments align with study requirements.

2 randomization

Participants are randomly assigned to one of two groups: one receiving teclistamab alone, and the other receiving a combination of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd).

3 treatment phase

For those in the teclistamab group, the medication is administered via subcutaneous injection. The frequency and dosage are determined by the study protocol.

Participants in the PVd group receive pomalidomide orally in capsule form, bortezomib as a subcutaneous injection, and dexamethasone orally in tablet form. Dosages and schedules are specified in the study protocol.

Participants in the Kd group receive carfilzomib as an infusion and dexamethasone orally. The dosage and frequency are outlined in the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests and other necessary evaluations.

Follow-up visits are scheduled according to the study timeline to ensure ongoing assessment of health status and treatment response.

5 completion of study

The study is estimated to conclude by December 19, 2030. Participants will have a final assessment to evaluate the overall outcomes of the treatment received.

Who Can Join the Study?

  • Must have a documented diagnosis of multiple myeloma, which is a type of blood cancer.
  • Must have a measurable disease at screening, which means certain levels of specific proteins in the blood or urine are present.
  • Must have received 1 to 3 previous treatments for multiple myeloma, including specific medications like an anti-CD38 monoclonal antibody and lenalidomide.
  • Must show evidence that the disease is getting worse or that the last treatment did not work, as determined by a doctor.
  • Must have an ECOG performance status score of 0 to 2, which is a scale used to assess how well a person can perform daily activities.
  • If female, must agree not to be pregnant, breastfeeding, or planning to become pregnant during the study and for 6 months after the last treatment.
  • Must be willing and able to follow the lifestyle restrictions required by the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than relapsed/refractory multiple myeloma. This means the cancer has returned or is not responding to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as the study includes both genders.
  • 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

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Hospital Jerez de la Frontera Jerez De La Frontera Spain
University Medicine Greifswald Greifswald Germany

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hopital Saint Antoine Paris France
Algemeen Ziekenhuis Klina Brasschaat Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Hospital Universitario Infanta Leonor Madrid Spain
Region Skane Helsingborg Hospital Helsingborg Sweden
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Region Dalarna Falun Sweden
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Kommunale Traegergesellschaft Cottbus mbH Cottbus Germany
Pratia Hematologia Sp. z o.o. Katowice Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Brno Brno Czechia
Champalimaud Clinical Centre Lisbon Portugal
Meander Medical Center Amersfoort The Netherlands
Hospital Universitario De Leon Leon Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Hospital Son Llatzer Palma Spain
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
CHU Helora La Louviere Belgium
Universita’ Campus Bio-medico Di Roma Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Odense University Hospital Odense Denmark
Universita’ Di Pisa Pisa Italy
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
University Hospital Ostrava Ostrava Czechia
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Uoditugouivf Micrnnm Ctbqveo Gzcxphzdq Groningen The Netherlands
Ilaokycn Ctyzvj Dgmbtxuosdcogiehe L'hospitalet De Llobregat Spain
Ggxzyxk Hgyfmqmk Ot Pagqwu Aydqb Apnpjzx Patras Greece
Hivdgttcrhrrktluaufhocu Zjzyflo gxlsc Zwickau Germany
Abzspumca Uzl Amsterdam The Netherlands
Aquvios Opgsoltujfk Ujdvsznarpvev Spuhlc Siena Italy
Aagpdiu Okgotlyszbq Uwetalxvtmuam Cbmnshxjcaio Dmjxy Sopunm E Djema Shvqdgt Dn Ttmsdp Turin Italy
Azbfbny Uiv Ikabk Dr Rkinyf Eqiuil Reggio Emilia Italy
Uxiltepgwmxsob Cdatego Kritixjjm Gdansk Poland
Apngpqp Uajgn Sedgvfsyv Lgrbzw Dz Bfpxuuq Bologna Italy
Ugxuxcw Umzrpoanbk Hehltlep Uppsala Sweden
Acyagw Uxmfxrmkbh Hygkaxgo Aarhus Denmark
Cbcj Dr Nrnwk Vandoeuvre Les Nancy France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
19.12.2022
Belgium Belgium
Not recruiting
19.12.2022
Czechia Czechia
Not recruiting
19.12.2022
Denmark Denmark
Not recruiting
19.12.2022
France France
Not recruiting
19.12.2022
Germany Germany
Not recruiting
19.12.2022
Greece Greece
Not recruiting
19.12.2022
Italy Italy
Not recruiting
19.12.2022
Poland Poland
Not recruiting
19.12.2022
Portugal Portugal
Not recruiting
19.12.2022
Spain Spain
Not recruiting
19.12.2022
Sweden Sweden
Not recruiting
19.12.2022
The Netherlands The Netherlands
Not recruiting
19.12.2022

Trial locations

Investigated drugs:

Teclistamab is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is being tested to see how well it works on its own in patients who have already tried other treatments.

Pomalidomide is a medication used to treat multiple myeloma. It works by helping the immune system attack cancer cells and by stopping the growth of these cells.

Bortezomib is a medication that treats multiple myeloma by interfering with the growth of cancer cells, eventually destroying them. It is often used in combination with other medications.

Dexamethasone is a type of steroid that helps reduce inflammation and is used in combination with other medications to treat multiple myeloma. It can help improve the effectiveness of cancer treatments.

Carfilzomib is a medication used to treat multiple myeloma by blocking certain proteins in cancer cells, which leads to their death. It is often used when other treatments have not been successful.

Investigated diseases:

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. Refractory multiple myeloma refers to the condition not responding to treatment or stopping responding after a while. The disease can cause bone pain, anemia, kidney problems, and increased risk of infections. It progresses by causing abnormal plasma cells to multiply uncontrollably, leading to damage in bones and other organs. Over time, the accumulation of these cells can interfere with the production of normal blood cells.

Trial ID:
2023-503444-13-00
Protocol code:
64007957MMY3006
Trial Phase:
Therapeutic confirmatory (Phase III)

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