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New drug combo shows promise in battling blood cancer

NCT ID NCT03617731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tests whether adding the drug isatuximab to standard treatment helps people with newly diagnosed multiple myeloma achieve deeper remission and live longer without the cancer progressing. About 662 participants will receive either standard therapy or standard therapy plus isatuximab, followed by maintenance treatment. The goal is to improve disease control, not to cure the disease, as ongoing treatment is needed.

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

662 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Jun 2028

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 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: 1. Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.) 2. Patient is eligible for high dose therapy and autologous stem cell transplantation. 3. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:2 * Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l) * Urine light-chain (M-protein) of ≥ 200 mg/24 hours * Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal 4. Age 18 - 70 years inclusive 5. WHO performance status 0-2 6. Negative pregnancy test at inclusion (females of childbearing potential) 7. All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section 6. For all men and females of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy. 8. All patients must * agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy * agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist 9. Ability of patient to understand character and individual consequences of the clinical trial 10. Provide written informed consent (must be available before enrolment in the trial) Exclusion Criteria 1. Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents. 2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow) 3. Plasma cell leukemia 4. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion 5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction \< 40% 6. 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 myeloma. 7. Patients with active or history of hepatitis B or C 8. HIV positivity 9. Patients with active, uncontrolled infections 10. Patients with severe renal insufficiency (Creatinine Clearance \< 30ml/min) 11. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0) 12. Patients with a history of 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 13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease 14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia 15. Platelet count \< 75 x 109/l 16. Haemoglobin \< 8.0 g/dl, unless related to myeloma 17. Absolute neutrophil count (ANC) \< 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed) 18. Corrected serum calcium \> 14 mg/dl (\> 3.5 mmol/l) 19. Unable or unwilling to undergo thromboprophylaxis 20. Pregnancy and lactation 21. Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months. 22. Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. No patients will be allowed to enrol in this trial more than once. \-

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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

  • Agaplesion Markus Krankenhaus, Med. Klinik I

    Frankfurt am Main, 60431, Germany

  • Asklepios Klinik Hamburg Altona, II. Med. Klinik

    Hamburg, D-22763, Germany

  • Asklepios Klinik Hamburg St. Georg

    Hamburg, 20099, Germany

  • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

    Paderborn, 33098, Germany

  • Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - Hämatologie und internistische Onkologie

    Ulm, 89081, Germany

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

    Cottbus, 03048, Germany

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389, Germany

  • Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (Hämatologie/Onkologie)

    Berlin, 12200, Germany

  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

    Schwäbisch Hall, 74523, Germany

  • Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

    Essen, D-45239, Germany

  • Gemeinschaftspraxis Prof. Dr. Michael Kiehl und Dipl. Med. Wolfgang Stein

    Frankfurt (Oder), 15236, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie am Caritas Krankenhaus

    Lebach, 66822, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie, Onkologisches Zentrum

    Saarlouis, 66740, Germany

  • HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

    Berlin, 13125, Germany

  • HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf

    Duisburg, 47166, Germany

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

    Bad Saarow, 15526, Germany

  • III. Medizinische Klinik Hämatologie und Internistische Onkologie

    Mannheim, 68167, Germany

  • Immunologisch-onkologisches MVZ am Siloah Krankenhaus

    Hanover, 30449, Germany

  • Johanniter Krankenhaus Bonn

    Bonn, 53113, Germany

  • KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie

    Hanover, 30459, Germany

  • Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

    Hagen, D-58095, Germany

  • Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik für Hämatologie - Onkologie

    Goch, 47574, Germany

  • Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bielefeld, D-33604, Germany

  • Klinikum Chemnitz GmbH, Innere Medizin III

    Chemnitz, D-09116, Germany

  • Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

    Darmstadt, D-64283, Germany

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236, Germany

  • Klinikum Fulda, Klinisches Studienzentrum GmbH

    Fulda, 36043, Germany

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290, Germany

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076, Germany

  • Klinikum Stuttgart, Stuttgart Cancer Center, Tumorzentrum Eva Mayr-Stihl

    Stuttgart, 70174, Germany

  • Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

    Regensburg, 93049, Germany

  • Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

    Mönchengladbach, D-41063, Germany

  • Krankenhaus Nordwest, Institut für Klinisch-Onkologische Forschung

    Frankfurt am Main, 60488, Germany

  • Krankenhaus St. Vincentius der evangelischen Stadtmission Heidelberg, Abt. Hämatologie, Onkologie, Rheumatologie

    Heidelberg, 69117, Germany

  • Mannheimer Onkologie Praxis

    Mannheim, D-68161, Germany

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

    Düsseldorf, 40479, Germany

  • Marien Hospital Herne

    Herne, 44625, Germany

  • Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen am Rhein, 67063, Germany

  • Medizinische Universitätsklinik, Knappschaftskrankenhaus

    Bochum, D-44892, Germany

  • Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

    Minden, 32429, Germany

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115, Germany

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, D-67346, Germany

  • Onkologisches Studienzentrum Darmstadt

    Darmstadt, 64283, Germany

  • Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

    Marburg, 35032, Germany

  • Praxisklinik für Hämatologie und Onkologie

    Koblenz, D-56068, Germany

  • Rems-Murr-Kliniken gGmbH

    Winnenden, 71364, Germany

  • SLK Kliniken Heilbronn, Med. Klinik III

    Heilbronn, D-74078, Germany

  • Schwarzwald-Baar Klinikum, Innere Medizin II

    Villingen-Schwenningen, 78052, Germany

  • St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie

    Eschweiler, 52249, Germany

  • Studiengesellschaft Onkologie Bielefeld GbR

    Bielefeld, 33604, Germany

  • Städtisches Klinikum Braunschweig, Med. Klinik III, Hämatologie und Onkologie

    Braunschweig, 38114, Germany

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133, Germany

  • Uniklinik Köln, Klinik I für Innere Medizin

    Cologne, 50937, Germany

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

    Aachen, 52074, Germany

  • University Hospital Heidelberg, Med. Klinik V

    Heidelberg, D-69120, Germany

  • University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

    Tübingen, D-72076, Germany

  • Universitätsklinik Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV

    Giessen, 35385, Germany

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

    Bonn, 53105, Germany

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

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

    Düsseldorf, D-40225, Germany

  • Universitätsklinikum Essen, Klinik für Hämatologie

    Essen, D-45147, Germany

  • Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

    Frankfurt am Main, 60590, Germany

  • Universitätsklinikum Hamburg Eppendorf, Zentrum für Onkologie, Studienzentrale der II. Medizinischen Klinik

    Hamburg, 20246, Germany

  • Universitätsklinikum Leipzig AöR, Medizinische Klinik und Poliklinik I-Hämatologie und Zelltherapie, Internistische Onkologie, Hämostaseologie

    Leipzig, 04103, Germany

  • Universitätsklinikum Münster, Med. Klinik A

    Münster, 48149, Germany

  • Universitätsklinikum des Saarlandes, Innere Medizin I

    Homburg (Saar), 66421, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

    Mainz, D-55131, Germany

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351, Germany

  • Westpfalz-Klinikum GmbH, Klinik für Innere Medizin I

    Kaiserslautern, 67655, Germany

  • ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

    Siegburg, D-53721, Germany

  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

    Bonn, 53113, Germany

More trials for these conditions

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