Study Comparing Talquetamab, Pomalidomide, and Teclistamab for Patients with Relapsed or Refractory Myeloma After 1 to 4 Prior Treatments

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What is this study about?

This clinical trial is focused on studying treatments for Relapsed or Refractory Multiple Myeloma, a type of blood cancer that has returned or is not responding to previous treatments. The study will explore different combinations of medications to find the most effective treatment. The medications being tested include Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Bortezomib, and Dexamethasone. Some of these medications are given as tablets or capsules, while others are administered through injections.

The purpose of the study is to compare the effectiveness of these medication combinations. Participants will be randomly assigned to receive one of the following treatments: Talquetamab with Pomalidomide, Talquetamab with Teclistamab, or a combination chosen by the investigator, which could be Elotuzumab, Pomalidomide, and Dexamethasone, or Pomalidomide, Bortezomib, and Dexamethasone. Some participants may receive a placebo. The study will last for a period of up to 24 months, during which participants will receive regular treatments and check-ups to monitor their health and the progress of the disease.

Throughout the study, the main focus will be on measuring how long participants live without the disease getting worse, known as progression-free survival. This will help researchers understand which treatment combination works best for patients with relapsed or refractory multiple myeloma. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. The study involves comparing different combinations of medications for treating relapsed or refractory myeloma.

2 treatment group assignment

The patient may be assigned to one of the following treatment groups: Talquetamab with Pomalidomide (Tal-P), Talquetamab with Teclistamab (Tal-Tec), or the investigator’s choice of either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd).

3 medication administration

The medications will be administered in various forms: oral tablets or capsules, subcutaneous injections, or intravenous infusions. The specific medications and their administration routes are as follows:

Dexamethasone: Oral tablets.

Pomalidomide: Oral capsules.

Talquetamab: Subcutaneous injection.

Teclistamab: Subcutaneous injection.

Bortezomib: Subcutaneous injection.

Elotuzumab: Intravenous infusion.

4 treatment duration

The treatment will continue as per the study protocol, with regular monitoring and assessments to evaluate the patient’s response to the treatment. The study aims to compare the effectiveness of the different treatment combinations.

5 monitoring and assessments

Throughout the study, the patient’s health and response to the treatment will be closely monitored. This includes regular check-ups, laboratory tests, and assessments to track the progression of the disease and any side effects of the medications.

6 study completion

The study is expected to conclude by June 2027. Upon completion, the results will be analyzed to determine the most effective treatment combination for relapsed or refractory myeloma.

Who Can Join the Study?

  • Be at least 18 years old or the legal age of consent in the area where the study is happening.
  • Have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer, as defined by specific medical criteria.
  • Have a measurable disease at the time of screening, which means the disease can be detected and measured by tests. This can be shown by certain levels of proteins in the blood or urine.
  • Have a relapsed or refractory disease. Relapsed means the disease returned after responding to treatment. Refractory means the disease did not respond well to treatment.
  • Show evidence of the disease getting worse or not responding to the last treatment, as determined by the study doctor.
  • Have an ECOG performance status score of 0, 1, or 2. This score is used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but able to do most self-care activities.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Locale Di Taranto Taranto Italy
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
St. Antonius Ziekenhuis Nieuwegein The Netherlands
University Hospital Olomouc Olomouc Czechia
Huoy Hipudljb Hague The Netherlands
Umozfnmidp Oo Dgmydflh Debrecen Hungary
Iywkxyno Pyvlngcvvgopsqo Comnej Cutgrk Marseille France
Hgfibdve Vhwo dmuhajrl Barcelona Spain
Ogffxn Uwjjhdhmjg Hpnotalm Odense Denmark
Umbsmmiqywwvslvsywroz Tbtwzoiad Ami Tuebingen Germany
Fgzfcfhpew Irxwu Cw Gxvjkw Owoiwvsq Myjowbmx Puqrbwduwae Milan Italy
Fylufcvise Iwsvy Pgluvxyrrqh Squ Mtcxna Pavia Italy
Rzeidc Sqqqe Sedadd Udhrasiokkvbmklzubd Lund Sweden
Uvgivkckgboxtyefq Dzcrb Shmjt Dg Vxjnvh Verona Italy
Amkhaxeir Hslkabex Athens Greece
Utdrqwk Uzfftcqcvs Hvzejnhv Uppsala Sweden
Fsvyoidk Nvphwljdb Btmx Brno Czechia
Cgdssu Hunnjlduobk Rkxdmpvx Ubnngtvsisfmk Df Tccai Tours France
Iwlmp Oubnfgxr Pfhkyklkdww Swj Myixvkd Genoa Italy
Utcsrjoclnyw Ds Ssnagryx Dq Cpvqxqutmk Santiago De Compostela Spain
Ayyvhva Osjvsvwlsic Ucyayzkcdhsiy Ctumplpeqtdd Dawrv Sqorfl E Dlisa Slcblpc Da Tjguyo Turin Italy
Ubbdkapvvhzobjjtacknk Hfbpeggore Aiu Heidelberg Germany
Uexqdxxvyp Oz Sxhjju Szeged Hungary
Apslggk Ufmpd Smxpquflh Lgdrdi Dm Bsiessc Bologna Italy
Ucniviiqreua Zppbgfmank Gmkd Gent Belgium
Coyzgj Hhgulultgcn Lwoc Sbf Pierre Benite France
Hqmmeygt Usdizhleveifq Mapptnw Dl Vojizhnlxd Santander Spain
Sceyod Do Sdwhf Dz Ltv Iolim Bcyfrxn Palma Spain
Fvogfknmj Pecq Lm Ioppsqmhzmxqi Brdhwnumz Dzu Hiqjriuk Uvbxwlucgssor Lf Pud Madrid Spain
Cvciket Ocflfibmf Znqtp Lerdjiatgc Ici Snx Jzbk Z Dqzpw Lublin Poland
Vkioj Sint-Niklaas Belgium
Sswnl Wppr Wvujlk Gslpkgldlcvmrymtnx Vienna Austria
Hzxoetvs Uyyvcygbwclva Vhqbzf Dd Lqw Nbshqf Granada Spain
Tcbwaugraz Cctmru Hweqscby Thessaloniki Greece
Feyufsxc Nfkuuewkm Ootuhuf Ostrava Czechia
Cmapqzvwq Zmcxobcgkr Szptxuavk Eindhoven The Netherlands
Akdnzq Uxnvpivmdc Hmcwizok Aarhus Denmark
Swjsejbnclbggkwduyveoj Vmnsjbtoc Ombjphedgrni Nyiregyhaza Hungary
Huonrqhb Uuniyicjenefb Dktgoedp Donostia / San Sebastian Spain
Hejuokoc Uoernxfmyhvar Lwhrb Andpzik Lugo Spain
Anjveqy Okbgrvbgnsf Nsmjlmjjj Sc Aavjnkv E Bonxpd E C Akdamw Asyvugplpyc Alexandria Italy
Sjfuxkfukolwuu Czdqjoh Obnzevpug Shogzsaxhgo Pveopfmlp Zqbbuf Ohsfpn Zibljpfbqf W Kkfckqda Kielce Poland
2eq Alr Fwuin Gitelha Hqsrfxda Athens Greece
Zwyqybmglt Onwx Lysldbw Genk Belgium
Uwsxtfjflh Ob Pzwc Pecs Hungary
Avmaouo Uvvxg Shhooxauo Lpwvpb Dghll Rudgnoo Faenza Italy
Ruuica Vwntvaqihsvtz Umea Sweden
Iuqgk Kicsocfwp Suibzlneo Zwolle The Netherlands
Mbrpzhhtdyrbcubibighkmfflr Hbzxkdqkgexdjdbs Halle (Saale) Germany
Ufglndttomevfmpzttfay Afpymwhd Augsburg Germany
Aooei Guclugqml Dv Cngxjst Catania Italy
Hootgwoc Szz Pkwyi Dy Axlbvmxsj Caceres Spain
Apdb Dn Snalo Dh Brgucn Y Sjdmd Burgos Spain
Gjzmi Hkvezng Dh Cfdwbjfku Charleroi Belgium
Smvw Cnqxu Gpxgeypjbg Salzburg Austria
Ssycmwk Snasotqmlwaqlak W Bkjiaqjea Pylhvxrwkff Oshirdu Ofjqprigqbnq Iwnofbfsxagcbmklszo Brzozow Poland
Fiipvqegjrccqze Sjiejcfll Almere The Netherlands
Adajxhu Sjekk Sruuqjvzf Twmlgmmgjzut Oxphu Mcrexguz Legnano Italy
Aldqlid Shuvvdcvw Lcqcvi Da Pmqhbbx Pescara Italy

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
22.02.2024
Belgium Belgium
Not recruiting
22.02.2024
Czechia Czechia
Not recruiting
22.02.2024
Denmark Denmark
Not recruiting
22.02.2024
France France
Not recruiting
22.02.2024
Germany Germany
Not recruiting
22.02.2024
Greece Greece
Not recruiting
22.02.2024
Hungary Hungary
Not recruiting
22.02.2024
Italy Italy
Not recruiting
22.02.2024
Poland Poland
Not recruiting
22.02.2024
Spain Spain
Not recruiting
22.02.2024
Sweden Sweden
Not recruiting
22.02.2024
The Netherlands The Netherlands
Not recruiting
22.02.2024

Trial locations

Talquetamab: This medication is being tested in combination with other treatments to see how well it works for patients with relapsed or refractory myeloma. It is a new type of therapy that targets specific proteins on cancer cells to help the immune system attack them.

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

Teclistamab: This is an investigational drug being studied for its potential to treat multiple myeloma. It is designed to help the immune system recognize and destroy cancer cells.

Elotuzumab: This medication is used in combination with other drugs to treat multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to attack them.

Bortezomib: This is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, eventually leading to their death.

Dexamethasone: This is a steroid medication used to reduce inflammation and suppress the immune system. In cancer treatment, it is often used to help reduce side effects and improve the effectiveness of other cancer therapies.

Investigated Diseases:

Relapsed or Refractory Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the myeloma has either returned after treatment (relapsed) or has not responded to treatment (refractory). The disease progresses as abnormal plasma cells multiply, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the disease can cause significant damage to bones and other organs. The progression of the disease varies, and it can become more challenging to manage as it advances.

Trial ID:
2022-502446-27-00
Protocol code:
64407564MMY3009
Trial Phase:
Therapeutic confirmatory (Phase III)

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