Study Comparing Subcutaneous and Intravenous Isatuximab with Pomalidomide and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called multiple myeloma, which affects plasma cells in the bone marrow. The study is testing a combination of medications to see how well they work together. The medications being tested include isatuximab, pomalidomide, and dexamethasone. Isatuximab is given in two different ways: as a subcutaneous injection (under the skin) and as an intravenous infusion (into a vein). Pomalidomide and dexamethasone are taken orally in capsule and tablet forms, respectively.

The purpose of the study is to compare the effectiveness of the subcutaneous and intravenous methods of administering isatuximab when used with pomalidomide and dexamethasone. Participants in the study will receive one of these combinations and may also receive a placebo. The study will last for a period of up to 80 weeks, during which participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect information on how well the treatment works, how the body processes the medications, and the overall health and satisfaction of the participants. This information will help determine if the subcutaneous method of administering isatuximab is as effective as the intravenous method, potentially offering a more convenient option for patients with multiple myeloma in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to multiple myeloma, including previous treatments and measurable protein levels.

2 initial assessment

An initial assessment is conducted to establish baseline health status and to collect necessary medical history.

3 treatment phase

The treatment involves a combination of medications: pomalidomide, isatuximab, and dexamethasone.

Pomalidomide is administered orally in capsule form, with available dosages of 1 mg, 2 mg, 3 mg, and 4 mg.

Isatuximab is administered either intravenously or subcutaneously, depending on the study group assignment.

Dexamethasone is taken orally in tablet form, with dosages of 4 mg and 8 mg.

4 medication schedule

The specific dosage and frequency of each medication are determined by the study protocol and may vary based on individual response and tolerance.

5 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness of the treatment and to track any side effects.

Assessments include blood tests, imaging studies, and questionnaires to evaluate health status and quality of life.

6 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

7 follow-up

Follow-up visits are scheduled to monitor long-term health outcomes and to gather additional data on the treatment’s effectiveness.

Who Can Join the Study?

  • Participants must have a type of cancer called multiple myeloma that has come back after treatment.
  • Participants should have received at least one previous treatment for multiple myeloma. This treatment must have included a medicine called lenalidomide and a type of medicine known as a proteasome inhibitor, either alone or together.
  • Participants need to have certain levels of a protein in their blood or urine. This includes:
    • Serum M-protein of at least 0.5 grams per deciliter (g/dL).
    • Urine M-protein of at least 200 milligrams in a 24-hour period.
    • A test called the serum free light chain (FLC) assay with specific results: involved FLC assay of at least 10 milligrams per deciliter (mg/dL) and an abnormal serum FLC ratio, which means less than 0.26 or more than 1.65.
  • Participants can be of any gender.
  • Participants must be adults, which means they are 18 years or older.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have a medical condition that could interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have a history of certain serious medical conditions, such as heart disease or liver problems.
  • Patients who are taking medications that could interfere with the study drugs.
  • Patients who have an active infection that requires treatment.

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
Klinikum Nuernberg Nürnberg Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
University General Hospital Of Ioannina Ioannina Greece
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universita’ Politecnica Delle Marche Ancona Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Centre Hospitalier De Perigueux Perigueux France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
University Hospital Ostrava Ostrava Czechia
Soedersjukhuset AB Stockholm Sweden
Crwioa Lhtw Bqaotj Lyon France
Hhcypgaz Uzrcneictyazf Mbbfvzy Dr Vgbydlvnhf Santander Spain
Dacznywqxpwk Cbslsbs Oqrvqrqkv Pxcbyzvckfku I Hzyvhtiqfif Wroclaw Poland
Imgrtjwt Romombgxg Pyg Ly Sycjxa Dtw Tbyelh Dwov Ancpdie Iqtb Skdsbj Meldola Italy
Ceggem Hmplcgxggqp Rluwprge Uricmfipcuufv Df Tkhwi Tours France
Abarrbl Uablr Splekuwve Lcswvk Dq Bwmlnrp Bologna Italy
Hsrjc Mxxky Ov Rfljnjt He Aalesund Norway
Imclqnuf Cvpyei Drdlelempamxlbnzq L'hospitalet De Llobregat Spain
Fekksxerr Payo Lh Igxhgywgnysmf Bxdhexfaj Dig Hinocykc Uffwseyaffheq Lb Pkz Madrid Spain
Iurxzhry dl Crmkuucamyad Hlmgihpverg Uvvyqmstlgdwr ds Sstbv Ejmohrx (crimwen Saint Priest En Jarez France
Ejwebvenugbdmhumjuofnrusdp Hdojescr oo Aqtpkz Athens Greece

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
10.11.2022
France France
Not recruiting
10.11.2022
Germany Germany
Not recruiting
10.11.2022
Greece Greece
Not recruiting
10.11.2022
Hungary Hungary
Not recruiting
10.11.2022
Italy Italy
Not recruiting
10.11.2022
Norway Norway
Not recruiting
10.11.2022
Poland Poland
Not recruiting
10.11.2022
Spain Spain
Not recruiting
10.11.2022
Sweden Sweden
Not recruiting
10.11.2022

Trial locations

Isatuximab: This medication is used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, isatuximab is being tested in two forms of administration: subcutaneous (under the skin) and intravenous (into a vein).

Pomalidomide: This is a medication that helps to slow down or stop the growth of cancer cells. It is used in combination with other drugs to treat multiple myeloma, especially in patients who have not responded to other treatments. Pomalidomide works by affecting the immune system and has anti-cancer properties.

Dexamethasone: This is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, dexamethasone is used to help enhance the effects of other cancer treatments and manage symptoms associated with the disease.

Investigated diseases:

Plasma Cell Myeloma Recurrent – Plasma cell myeloma, also known as multiple myeloma, is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In recurrent cases, the disease returns after a period of improvement or remission. It typically progresses by causing an overproduction of abnormal plasma cells, which can crowd out healthy blood cells and lead to bone damage, kidney problems, and weakened immune function. Symptoms may include bone pain, fatigue, frequent infections, and anemia. The disease can vary in its rate of progression, with some individuals experiencing slow development while others may have a more aggressive form.

Trial ID:
2023-508869-32-00
Protocol code:
EFC15951
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study Comparing Continuous and Fixed Duration Therapy with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Relapsed Multiple Myeloma

    Recruiting

    3 1 1 1
    France