Study Comparing Selinexor, Pomalidomide, and Dexamethasone with Elotuzumab, 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 (RRMM), which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare two different treatment combinations to see which is more effective. One combination includes the medications Selinexor, Pomalidomide, and Dexamethasone (referred to as SPd), while the other includes Elotuzumab, Pomalidomide, and Dexamethasone (referred to as EloPd). These medications are used to help control the growth of cancer cells and manage the disease.

The purpose of the study is to determine which combination of treatments is more effective in managing RRMM. Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how the disease responds to the treatments. The medications will be administered in different forms, such as tablets, capsules, or injections, depending on the specific drug. The study will also look at the safety and tolerability of these treatments, which means checking for any side effects or health changes that occur during the study.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the disease. The study will help researchers understand which treatment combination works better for patients with RRMM and could lead to improved treatment options in the future. The study is expected to continue until 2028, providing valuable information on the effectiveness and safety of these treatment combinations for RRMM.

1 initial visit and randomization

Upon joining the study, you will attend an initial visit where you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

2 treatment group assignment

You will be assigned to either the SPd group, which includes selinexor, pomalidomide, and dexamethasone, or the EloPd group, which includes elotuzumab, pomalidomide, and dexamethasone.

3 medication administration

If you are in the SPd group, you will take selinexor orally, pomalidomide orally, and dexamethasone orally. The specific dosages and frequency will be provided by the study team.

If you are in the EloPd group, you will receive elotuzumab through an intravenous infusion, and take pomalidomide and dexamethasone orally. The specific dosages and frequency will be provided by the study team.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your health and response to the treatment. These visits will include physical examinations, blood tests, and other necessary assessments.

5 quality of life assessments

Throughout the study, you will be asked to complete questionnaires about your quality of life. These assessments help understand the impact of the treatment on your daily activities and overall well-being.

6 end of treatment

At the end of the treatment period, you will have a final visit to assess your health and discuss the next steps. This may include transitioning to other treatments or follow-up care as needed.

Who Can Join the Study?

Must have Relapsed or Refractory Multiple Myeloma (RRMM) with measurable disease.
Must be at least 18 years old.
Must have signed a written informed consent form.
Must have received at least 1 and no more than 4 prior treatments for multiple myeloma.
Must have had prior therapy that includes at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor.
Must have had prior therapy with an anti-CD38 monoclonal antibody as part of the last treatment before joining the study.
Must have an ECOG performance status of 2 or less. (This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.)
Must have adequate liver function within 28 days before starting the study.
Must have adequate kidney function within 28 days before starting the study.
Must have adequate blood cell counts within 7 days before starting the study.
Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
Male patients must agree to use effective contraception during the study and for 90 days after the last dose and must not donate sperm during this time.
Patients with hepatitis B can participate if they have been treated for more than 8 weeks and have a low viral load.
Patients with a history of hepatitis C can participate if they have been successfully treated and have a low viral load.
Patients with a history of HIV can participate if they have a certain level of immune cells, no recent serious infections, and are on stable antiretroviral therapy.
Must be able and willing to take aspirin or other blood thinners as needed.

Who Cannot Join the Study?

Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. This is a type of blood cancer that has returned after treatment or did 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 and may vary.
Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study and includes specific characteristics or conditions.
Patients who are not able to provide informed consent or are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have limited ability to make informed decisions about their participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Medicine Greifswald	Greifswald	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Sanitaria Locale Roma 2	Rome	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Amphia Hospital	Breda	The Netherlands
Azienda Socio Sanitaria Territoriale Ovest Milanese	Legnano	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Evangelismos S.A.	Athens	Greece
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Marien Hospital Duesseldorf GmbH	Duesseldorf	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Hospital Universitario De Leon	Leon	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
General University Hospital Of Patras	Patras	Greece
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Uruchtvfta Mecywbv Cwtkha Hyxsqqgpyhmnxhzgg	Hamburg	Germany
Hzxymujg Ugcsxgpwspaat Movmqhq Du Vnxvjplaqa	Santander	Spain
Ixuwcrqg Csybjd Dabdukyndpcvoziry	L'hospitalet De Llobregat	Spain
Tngdzonlgk Cyyhwr Heluoiyc	Thessaloniki	Greece
Irvxlaec Rxnqvdpku Pxl Lf Szazcs Dbh Tjgutu Djmw Anwlgoh Iich Sdwocc	Meldola	Italy
Ewsnrkc Uypgrpfweggu Maameqw Cethfdo Rlwchzsio (czzqzqd Mkn	Rotterdam	The Netherlands
Atkodje Ocyvsjiecka Uwkxwsasvpyld Cvzrxnbgvxuf Dpwzn Svfzbz E Dngib Sdtodcc Dz Tzvffb	Turin	Italy
Asgdqrg Uhgah Scwjsauoh Lzwdxu Dg Bdsbhim	Bologna	Italy
Ayuneol Oskzbngxfwn Ppjm Gsebkqnx Xgdng	Bergamo	Italy
Hpvcungj Vbre dsbhdkhg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.02.2022
Germany	Not recruiting	01.02.2022
Greece	Not recruiting	01.02.2022
Italy	Not recruiting	01.02.2022
Spain	Not recruiting	01.02.2022
The Netherlands	Not recruiting	01.02.2022

Trial locations

Investigated drugs:

Selinexor is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It works by blocking a protein in cancer cells that helps them grow and survive. By stopping this protein, selinexor can help slow down or stop the growth of cancer cells.

Pomalidomide is another medication used in the trial for treating multiple myeloma. It helps the immune system fight cancer by boosting the body’s natural defenses. Pomalidomide also works to stop cancer cells from growing and spreading.

Dexamethasone is a type of steroid used in this trial. It helps reduce inflammation and can also kill cancer cells or make them more sensitive to other cancer treatments. In this trial, dexamethasone is used alongside other medications to enhance their effectiveness against multiple myeloma.

Elotuzumab is a medication used in the trial that targets a specific protein found on the surface of multiple myeloma cells. By attaching to this protein, elotuzumab helps the immune system recognize and attack the cancer cells, which can help control the disease.

Investigated diseases:

Plasma cell myeloma

Relapsed or Refractory Multiple Myeloma – Multiple Myeloma 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 or refractory cases, the disease has returned after treatment or does not respond to therapy. The disease progresses as abnormal plasma cells multiply, leading to bone damage, kidney problems, and weakened immune function. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of these abnormal cells can cause anemia and other blood-related issues. The progression of the disease can vary, with periods of stability followed by worsening symptoms.

Trial ID:

2024-518304-53-00

Protocol code:

ENM29

NCT ID:

NCT05028348

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Selinexor, Pomalidomide, and Dexamethasone with Elotuzumab, Pomalidomide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?