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New combo therapy aims to deepen remission in multiple myeloma

NCT ID NCT06216158

Disease control Sponsor: University of Heidelberg Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding isatuximab to iberdomide maintenance therapy after a stem cell transplant can reduce cancer cells in the bone marrow more than iberdomide alone. About 411 adults with newly diagnosed multiple myeloma will participate. The goal is to see if the combination leads to deeper, longer-lasting remission.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 411 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Prior inclusion and treatment within the GMMG-HD8 / DSMM XIX trial OR * Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) \[e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalidomide and dexamethasone\] with an anti-CD38 monoclonal antibody (isatuximab or daratumumab) * Post HDM/ASCT consolidation containing similar substances as induction therapy is permitted * Induction and consolidation therapy should make up a total of at least 4 up to 6 cycles, with a maximum of 2 consolidation cycles post HDM/ASCT AND * Received at least one cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT) * At least Partial Response (PR) according to IMWG criteria at inclusion in the trial * Age of at least 18 years at trial inclusion * WHO performance status of 0, 1, or 2 * Negative pregnancy test at inclusion (women of childbearing potential) * For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy * Ability of patient to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide * Patient has known hypersensitivity (or contraindication) to any of the components of study therapy that are not amenable to premedication with steroids or H1 blockers and that would prohibit further treatment with these agents (e.g. known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80 as well as intolerance to arginine and Poloxamer 188) * Patients with a history of serious allergic reaction to another immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide)", as angioedema and severe dermatologic reactions, including Grade 4 rash and exfoliative or bullous rash * Patients currently being treated with strong inhibitors or inducers of CYP3A4/5 * Systemic AL amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow), plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities or Waldenström macroglobulinemia. * Previous systemic anti-myeloma treatment other than administered within the GMMG-HD8 / DSMM XIX trial or other than defined in the inclusion criteria above (including up to two cycles cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT). Local, consolidative radiotherapy for myeloma disease is permitted unless performed in case of progressive disease according to IMWG criteria * Severe cardiac dysfunction (NYHA classification III-IV) * Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to MM or HDM/ASCT. * Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C. In case of history of hepatitis B or C, it must be clarified whether it has been overcome and negative circulating HBV-DNA or HCV-RNA must be provided. Positive hepatitis B status may only be acceptable in absence of circulating HBV-DNA or signs of chronic or acute infection and if an adequate prophylaxis is being implemented during the course of the study. Prophylaxis for patients with history of hepatitis B or C should be set on a patient individual basis. * HIV positivity * Patients with active, uncontrolled infections * Patients with severe renal insufficiency (Creatinine Clearance \< 30ml/min) or requiring hemodialysis * Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE, version 5.0) * Patients with a history of any active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy. A history of an early stage malignancy during the past 5 years may be acceptable, however, in this case the GMMG study office has to be consulted prior to study inclusion * Patients with acute diffuse infiltrative pulmonary and/or pericardial disease * Autoimmune haemolytic anaemia with positive indirect Coombs test or immune thrombocytopenia * Platelet count \< 75 x 109/l * Haemoglobin ≤ 8.0 g/dl, unless related to MM * Absolute neutrophil count (ANC) \< 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed) * Corrected serum calcium \> 14 mg/dl (\> 3.5 mmol/l) * Unable or unwilling to undergo thromboprophylaxis * Pregnancy and lactation * Participant has any concurrent severe and/or uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study * Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities * Participation in other interventional clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Brüderkrankenhaus St. Josef

    Paderborn, 33098, Germany

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

    Cottbus, 03048, Germany

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389, Germany

  • Charité, III. Medizinische Abteilung

    Berlin, 12200, Germany

  • Diakoneo Diak Klinikum

    Schwäbisch Hall, 74523, Germany

  • Evangelisches Klinikum Bethel

    Bielefeld, 33611, Germany

  • Gemeinschaftsklinikum Mittelrhein Koblenz

    Koblenz, 56073, Germany

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526, Germany

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Johanniter Krankenhaus

    Bonn, 53113, Germany

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

    Essen, 45239, Germany

  • Katholisches Krankenhaus Hagen

    Hagen, 58097, Germany

  • Klinik Ottakring Wien

    Vienna, 1160, Austria

  • Kliniken Maria Hilf

    Mönchengladbach, 41063, Germany

  • Kliniken Ostalb

    Mutlangen, 73557, Germany

  • Klinikum Chemnitz

    Chemnitz, 09116, Germany

  • Klinikum Darmstadt GmbH, Medizinische Klinik V

    Darmstadt, 64283, Germany

  • Klinikum Hochsauerland

    Meschede, 59870, Germany

  • Klinikum Oldenburg

    Oldenburg, 26133, Germany

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076, Germany

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600, Austria

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

    Jena, 07740, Germany

  • Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital

    Stuttgart, 70174, Germany

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063, Germany

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

  • Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie

    Kempten, 87439, Germany

  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

    Regensburg, 93049, Germany

  • Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin III

    Salzburg, 5020, Austria

  • Malteser Krankenhaus

    Flensburg, 24939, Germany

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

    Düsseldorf, 40479, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Oncocare, Gemeinschaftspraxis für Hämatologie und Onkologie

    Lebach, 66822, Germany

  • Onkologie Praxis

    Mannheim, 69161, Germany

  • Onkologische Schwerpunktpraxis

    Heidelberg, 69115, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604, Germany

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, 67346, Germany

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Philipps-Universität Marburg Hämatologie/Onkologie

    Marburg, 35043, Germany

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376, Germany

  • Rotkreuzklinikum

    München, 80634, Germany

  • SLK Kliniken Heilbronn, Medizinische Klinik III

    Heilbronn, 74078, Germany

  • Schwarzwald Baar Klinikum

    Villingen-Schwenningen, 78052, Germany

  • St. Antonius-Hospital

    Eschweiler, 52249, Germany

  • St. Johannes Hospital Dortmund

    Dortmund, 44137, Germany

  • Städtisches Klinikum

    Braunschweig, 38114, Germany

  • Städtisches Klinikum

    Dessau, 06847, Germany

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

    Aachen, 52074, Germany

  • University of Würzburg, Med. Klinik und Poliklinik II

    Würzburg, 97080, Germany

  • Universitätsklinikum

    Augsburg, 86156, Germany

  • Universitätsklinikum

    Ulm, 89081, Germany

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Medizinische Klinik V

    Heidelberg, 69120, Germany

  • Universitätsklinikum Krems an der Donau

    Krems, 3500, Austria

  • Universitätsklinikum Mannheim, III. Medizinische Klinik

    Mannheim, 68167, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1

    Homburg, 66421, Germany

  • Universitätsmedizin Greifswald

    Greifswald, 17475, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, 55131, Germany

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351, Germany

  • Westpfalz-Klinikum

    Kaiserslautern, 67655, Germany

  • ZAHO - Zentrum für ambulante Hämatologie und Onkologie

    Siegburg, 53721, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.