RecruitingPhase 3NCT06216158

Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

A Randomized Phase III Trial Assessing Iberdomide Versus Iberdomide Plus Isatuximab Maintenance Therapy Post Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Sponsor

University of Heidelberg Medical Center

Enrollment

411 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Patients with newly-diagnosed multiple myeloma who underwent a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT can also be recruited. The main question it aims to answer is: • Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two maintenance therapy options after a stem cell transplant for newly diagnosed multiple myeloma (a blood cancer): iberdomide alone versus iberdomide combined with isatuximab (a CD38-targeting antibody). Maintenance therapy is given after the main treatment to keep the cancer in remission for as long as possible. **You may be eligible if...** - You have newly diagnosed multiple myeloma - You received a quadruplet induction regimen (a 4-drug combination including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) - You received at least one round of high-dose chemotherapy followed by an autologous stem cell transplant (using your own stem cells) - You achieved at least a partial response to treatment - You are 18 or older and in reasonably good health - You are willing to use contraception and give written informed consent **You may NOT be eligible if...** - You have gastrointestinal problems that would significantly affect how your body absorbs iberdomide - You have known allergies or contraindications to any of the study drugs - You are pregnant or breastfeeding - You have certain serious infections or other active cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIberdomide

Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)

DRUGIsatuximab

Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)

DRUGDexamethasone

Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)

Locations(69)

Universitätsklinikum Krems an der Donau

Krems, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin III

Salzburg, Austria

Klinik Ottakring Wien

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, Germany

Universitätsklinikum

Augsburg, Germany

Helios Klinikum Bad Saarow

Bad Saarow, Germany

Charité, III. Medizinische Abteilung

Berlin, Germany

Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

Berlin, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Evangelisches Klinikum Bethel

Bielefeld, Germany

Johanniter Krankenhaus

Bonn, Germany

Universitätsklinikum Bonn

Bonn, Germany

Städtisches Klinikum

Braunschweig, Germany

Klinikum Chemnitz

Chemnitz, Germany

Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik

Cottbus, Germany

Klinikum Darmstadt GmbH, Medizinische Klinik V

Darmstadt, Germany

Städtisches Klinikum

Dessau, Germany

St. Johannes Hospital Dortmund

Dortmund, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatalogie und Palliativmedizin

Düsseldorf, Germany

St. Antonius-Hospital

Eschweiler, Germany

KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

Essen, Germany

Malteser Krankenhaus

Flensburg, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Greifswald

Greifswald, Germany

Katholisches Krankenhaus Hagen

Hagen, Germany

Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

Hamburg, Germany

Asklepios Klinik Altona

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Onkologische Schwerpunktpraxis

Heidelberg, Germany

Universitätsklinikum Heidelberg, Medizinische Klinik V

Heidelberg, Germany

SLK Kliniken Heilbronn, Medizinische Klinik III

Heilbronn, Germany

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1

Homburg, Germany

Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie

Jena, Germany

Westpfalz-Klinikum

Kaiserslautern, Germany

Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie

Kempten, Germany

Gemeinschaftsklinikum Mittelrhein Koblenz

Koblenz, Germany

Oncocare, Gemeinschaftspraxis für Hämatologie und Onkologie

Lebach, Germany

Klinikum der Stadt Ludwigshafen

Ludwigshafen, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Universitätsmedizin der Johannes Gutenberg-Universität

Mainz, Germany

Universitätsklinikum Mannheim, III. Medizinische Klinik

Mannheim, Germany

Onkologie Praxis

Mannheim, Germany

Philipps-Universität Marburg Hämatologie/Onkologie

Marburg, Germany

Klinikum Hochsauerland

Meschede, Germany

Kliniken Maria Hilf

Mönchengladbach, Germany

Kliniken Ostalb

Mutlangen, Germany

Rotkreuzklinikum

München, Germany

Klinikum rechts der Isar der TU München

München, Germany

Klinikum Oldenburg

Oldenburg, Germany

Klinikum Osnabrück GmbH

Osnabrück, Germany

Brüderkrankenhaus St. Josef

Paderborn, Germany

Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

Regensburg, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Diakoneo Diak Klinikum

Schwäbisch Hall, Germany

ZAHO - Zentrum für ambulante Hämatologie und Onkologie

Siegburg, Germany

Onkologische Schwerpunktpraxis Speyer

Speyer, Germany

Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital

Stuttgart, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum

Ulm, Germany

Schwarzwald Baar Klinikum

Villingen-Schwenningen, Germany

University of Würzburg, Med. Klinik und Poliklinik II

Würzburg, Germany

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NCT06216158

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