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Study Comparing Talquetamab, Daratumumab, and Pomalidomide with Drug Combination for Patients with Relapsed or Refractory Multiple Myeloma

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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 several medications, including Pomalidomide, Daratumumab, Dexamethasone, and a medication with the code name JNJ-64407564, also known as Talquetamab. These treatments are being tested in different combinations to see how effective they are in treating patients whose multiple myeloma has returned or has not responded to previous treatments.

The purpose of the study is to compare the effectiveness of different combinations of these medications. Participants will receive one of the following treatment combinations: Talquetamab with Daratumumab and Pomalidomide (referred to as Tal-DP), Talquetamab with Daratumumab (referred to as Tal-D), or Daratumumab with Pomalidomide and Dexamethasone (referred to as DPd). The study will monitor participants over a period to assess how well these treatments work in controlling the disease.

Participants in the study will receive their assigned treatment and will be monitored regularly to track their health and the progression of their multiple myeloma. The study aims to find out which combination of treatments is most effective in prolonging the time before the disease worsens, known as progression-free survival. This information will help doctors understand better ways to treat multiple myeloma in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of relapsed or refractory multiple myeloma and ensuring previous treatment with at least one line of therapy.

2 randomization

Participants are randomly assigned to one of the treatment groups. The groups include combinations of medications such as talquetamab, daratumumab, pomalidomide, and dexamethasone.

3 treatment administration

The treatment involves the administration of medications through different routes. Talquetamab and daratumumab are given as subcutaneous injections. Pomalidomide and dexamethasone are taken orally in the form of capsules or tablets.

The specific dosage and frequency depend on the assigned treatment group. The treatment continues as per the study protocol.

4 monitoring and follow-up

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

Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

5 completion of study

The study is estimated to conclude by May 28, 2029. Upon completion, final assessments are conducted to evaluate the overall outcomes and progression-free survival.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer. This includes having a measurable level of a specific protein in the blood or urine, or an abnormal level of certain proteins in the blood.
  • The patient must have relapsed or refractory disease. Relapsed means the disease returned after responding to treatment. Refractory means the disease did not respond well to treatment.
  • The patient must have received at least one previous treatment for multiple myeloma, which included a proteasome inhibitor (a type of drug that blocks the action of proteasomes, which are part of the cell’s machinery) and lenalidomide (a medication used to treat multiple myeloma). If only one previous treatment was received, the patient must not have responded well to lenalidomide.
  • The patient must show evidence that the disease is getting worse, as determined by a doctor using specific criteria.
  • The patient must have an ECOG performance status score of 0, 1, or 2. This score is a way to measure how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must be an adult, as the study includes age categories 3 and 4, which typically refer to adults.
  • Both male and female patients can participate in the study.
  • The study may include individuals from vulnerable populations, which means people who might need special protection or consideration.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Relapsed or Refractory Multiple Myeloma cannot participate. Relapsed means the cancer has come back after treatment, and Refractory means the cancer does not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not part of the specific clinical trial group being studied cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
  • Patients who are not male or female cannot participate, as the study includes both male and female subjects.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may have a higher risk of harm or exploitation in a study.

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
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Universitaet Leipzig Leipzig Germany
Pomeranian Medical University Szczecin Poland
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hopital Saint Antoine Paris France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Hospital Universitario 12 De Octubre Madrid Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Maxima Medisch Centrum Veldhoven The Netherlands
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Fundacio Institut De Recerca De L’Hospital De La Santa Creu I Sant Pau Barcelona Spain
Azienda Ospedaliera di Padova Padua Italy
Pratia Hematologia Sp. z o.o. Katowice Poland
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hospital Universitario De Leon Leon Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
CHC MontLegia Liege Belgium
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Hospital Universitario De Canarias La Laguna Spain
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Hospital Ostrava Ostrava Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Cbwpjd Lkmu Bxpbsh Lyon France
Anxltdp Opheqsbbgiz Ojdzawex Rcmcoqs Vfftz Snibi Cdqhtahz Palermo Italy
Ulwrangstw Hjyugvot Crcdvtt Cologne Germany
Ejgovkb Umkdxygiafri Mingiiu Codlwem Rpovdzklt (irdmopg Mgt Rotterdam The Netherlands
Aijlkkc Ocayupasoca Uvhgmqsleceel Cdctbbdexqjv Dhdht Sdaaxx E Dxacl Sgymmgt Dt Tpprxc Turin Italy
Nxqotijt Irpljxrs Ooobzfnwx Igs Mlany Srnpulgksfrkoucmrenuyuzvjfmn Ifdyyyvf Btslzvju Cracow Poland
Afthykh Uwk Idffq Dr Rtcqzq Eubqus Reggio Emilia Italy
Aniebib Upigv Slbpwvort Lgguex Dr Blqhbmy Bologna Italy
Uoqegdlbgwhgnx Cfbnpnp Krhesdjqk Gdansk Poland
Uqunrcjljv Oi Ajsesax Edegem Belgium
Hmsqdafd Udqxolqkywmvx Hnkjsode Tjydq y Pekyox Iayhxayh Cyzavg dnkyfsuholpfgyvny (afgk Badalona Spain
Hxwzvqtm Vmpb dgmpolnz Barcelona Spain

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
13.10.2022
Czechia Czechia
Not recruiting
13.10.2022
France France
Not recruiting
13.10.2022
Germany Germany
Not recruiting
13.10.2022
Greece Greece
Not recruiting
13.10.2022
Italy Italy
Not recruiting
13.10.2022
Poland Poland
Not recruiting
13.10.2022
Spain Spain
Not recruiting
13.10.2022
The Netherlands The Netherlands
Not recruiting
13.10.2022

Trial locations

Investigated drugs:

Talquetamab: This is an investigational medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is administered under the skin (subcutaneously) and is being tested in combination with other medications to see if it can help control the disease in patients who have already received other treatments.

Daratumumab: This is a medication used to treat multiple myeloma. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy them. In this trial, it is given under the skin and is being used in combination with other treatments to evaluate its effectiveness.

Pomalidomide: This medication is used to treat multiple myeloma by helping the immune system attack cancer cells and by stopping the growth of these cells. It is taken orally and is being tested in combination with other drugs to determine its role in treating patients with relapsed or refractory multiple myeloma.

Dexamethasone: This is a type of steroid medication that helps reduce inflammation and is used to treat various conditions, including multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness and manage symptoms.

Investigated diseases:

Relapsed or 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 condition leads to the accumulation of abnormal plasma cells in the bone marrow, which can crowd out healthy blood cells. This can result in symptoms such as bone pain, anemia, kidney problems, and increased risk of infections. The disease typically progresses through cycles of remission and relapse, with each relapse potentially being more challenging to treat.

Trial ID:
2023-503467-41-00
Protocol code:
64407564MMY3002
Trial Phase:
Therapeutic confirmatory (Phase III)

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