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Needle vs. IV: which isatuximab method works best for myeloma?

NCT ID NCT05804032

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether a shot under the skin (subcutaneous) works as well as an IV drip for the drug isatuximab in people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. All participants also received standard chemotherapy. The goal was to see if the easier injection method is just as effective at controlling the disease.

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

514 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2026

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 to 70 years

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: * Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG) * Patient is eligible for high-dose melphalan (200 mg/m\^2 melphalan) and autologous stem cell transplantation * Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24 hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal * Age 18-70 years at trial inclusion Exclusion Criteria: * Patient has known hypersensitivity (or contraindication) to any of the components of study therapy * Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow) * Plasma cell leukemia * Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression * Severe cardiac dysfunction (NYHA classification III-IV) * Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C * HIV positivity * Patients with active, uncontrolled infections * Patients with severe renal insufficiency 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) * 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 * Platelet count \< 75 x 10\^9/L * Haemoglobin ≤ 8.0 g/dL, unless related to MM * Absolute neutrophil count (ANC) \< 1.0 x 10\^9/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) * Pregnancy and lactation For further details on inclusion/exclusion criteria please refer to the study protocol.

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Conditions

The condition(s) this trial relates to.

immunoproliferative disorder lymphoproliferative syndrome monoclonal gammopathy neoplasm 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 Kliniken Hamburg GmbH

    Altona, 20099, Germany

  • Bielefeld Praxis, Studiengesellschaft Onkologie

    Bielefeld, 33604, Germany

  • Brüderkrankenhaus St. Josef

    Paderborn, 33098, Germany

  • CaritasKlinikum Saarbrücken St. Theresia

    Saarbrücken, 66113, 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 (Hämatologie/Onkologie)

    Berlin, 12200, Germany

  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III (Tumorerkrankungen, Palliativmedizin)

    Schwäbisch Hall, 74523, Germany

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176, Germany

  • Evangelisches Klinikum Bethel

    Bielefeld, 33611, Germany

  • Gemeinschaftsklinikum Mittelrhein

    Koblenz, 56073, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Lebach, 66822, Germany

  • Gießen UK

    Giessen, 35385, Germany

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

    Wiesbaden, 65199, Germany

  • Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bad Saarow, 15526, Germany

  • Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2

    Duisburg, 47166, Germany

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283, Germany

  • Johanniter-Krankenhaus Bonn

    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 gGmbH, Klinik für Hämatologie und Onkologie

    Hagen, 58097, Germany

  • Klinik Oldenburg

    Oldenburg, 26133, Germany

  • Klinik Ottakring

    Vienna, 1160, Austria

  • Klinik für Hämatologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Kliniken Maria Hilf GmbH, Medizinische Klinik I

    Mönchengladbach, 41063, Germany

  • Kliniken Ostalb - Standort Stauferklinikum, Hämatologie und Onkologie

    Mutlangen, 73557, Germany

  • Klinikum Augsburg, II. Medizinische Klinik Hämatologie/Onkologie

    Augsburg, 86156, Germany

  • Klinikum Bremen-Mitte

    Bremen, 28205, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Klinikum Darmstadt, Medizinische Klinik V Hämatologie/Onkologie

    Darmstadt, 64283, Germany

  • Klinikum Hochsauerland

    Meschede, 59870, Germany

  • Klinikum Nürnberg

    Nuremberg, 90419, Germany

  • Klinikum Osnabrück

    Osnabrück, 49076, Germany

  • Klinikum Wels-Grieskirchen

    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 Technischen Universität München, Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie

    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 Feldkirch-Rankweil

    Rankweil, 6830, Austria

  • Malteser Krankenhaus, St. Franziskus Hospital, Hämatologie/Onkologie

    Flensburg, 24939, Germany

  • Mannheimer Onkologie Praxis

    Mannheim, 68161, Germany

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

    Düsseldorf, 40479, Germany

  • MedZentrum Klinikum Bayreuth GmbH

    Bayreuth, 95445, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115, Germany

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, 67346, Germany

  • Ordensklinikum Linz

    Linz, 4020, Austria

  • Philipps-Universität Marburg, Abteilung Hämatologie, Onkologie und Immunologie am Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35037, Germany

  • Phyrn-Eisenwurzen Klinikum Steyr

    Steyr, 4400, Austria

  • 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, Klinik für Hämatologie / Onkologie

    Eschweiler, 52249, Germany

  • St.-Johannes-Hospital

    Dortmund, 44137, Germany

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114, Germany

  • Städtisches Klinikum Dessau

    Dessau, 06847, Germany

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133, 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

  • Universität Tübingen, Medizinische Universitätsklinik, Innere Medizin II: Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie

    Tübingen, 72076, Germany

  • Universitätsklinikum Bonn, Medizinische Klinik III

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Frankfurt, Medizinische Klinik 2, Hämatologie/Onkologie

    Frankfurt am Main, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79110, Germany

  • Universitätsklinikum Göttingen

    Göttingen, 37075, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Medizinische Klinik V

    Heidelberg, 69120, Germany

  • Universitätsklinikum Krems

    Krems, 3500, Austria

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120, Germany

  • Universitätsklinikum Mannheim, III. Medizinische Klinik

    Mannheim, 68167, Germany

  • Universitätsklinikum Münster, 1. Medizinische Klinik A

    Münster, 48149, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538, Germany

  • Universitätsklinikum St. Pölten - Lilienfeld

    Sankt Pölten, 3100, Austria

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz

    Salzburg, 5020, Austria

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1

    Homburg, 66421, Germany

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C

    Greifswald, 17475, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Medizinische Klinik und Poliklinik

    Mainz, 55131, Germany

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351, Germany

  • Vivantes Klinikum Spandau

    Berlin, 13585, Germany

  • Westpfalz-Klinikum

    Kaiserslautern, 67655, Germany

  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

    Siegburg, 53721, Germany

More trials for these conditions

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