Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
NCT ID: NCT06216158
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
411 participants
INTERVENTIONAL
2024-04-05
2029-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
NCT03617731
Iberdomide and Daratumumab As Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
NCT06107738
Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
NCT05392946
Study of Iberdomide in People With Multiple Myeloma Who Have Had an Autologous Hematopoietic Stem Cell Transplant (AHCT)
NCT05354557
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
NCT06762769
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Investigational Medicinal Product: Iberdomid (oral), isatuximab (subcutaneous administration via a wearable injector system).
Randomisation will be performed centrally by GMMG/DSMM offices after verification of the eligibility of the patient. At the time of study inclusion, randomization will be performed into arm A (iberdomide) or arm B (iberdomide + isatuximab). Randomization will be stratified by centrally assessed MRD negativity status (yes vs. no vs. unknown); assessed by NGF from BMA; sensitivity of 10\^-5; independent of standard IMWG response) and number of HDM/ASCT (single vs. tandem).
Patients randomized in arm A will receive 39 cycles of the drug iberdomide, a Cereblon E3 Ubiquitin Ligase Modulating Drug (CELMoD®) that shares structural similarities to the immunomodulatory compounds (IMiDs) such as thalidomide and lenalidomide. Each cycle will last for 29 days. Patients in arm B will receive the same the 39 cycles of iberdomide plus monoclonal anti-CD38 antibody isatuximab subcutaneously. In both arms, patients will receive 20 mg dexamethasone in cycle 1, on the same days as the isatuximab administration in Arm B. End of study will be after 36 months of the maintenance therapy.
There is one primary objective:
\- Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD) negativity rates (sensitivity 2x10\^-6 via next-generation flow cytometry \[NGF\]) after two years of maintenance therapy.
There is one key secondary objective:
\- PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.
Further secondary objectives are:
* Rates of sustained MRD negativity (at sensitivity levels of 10-5 and 2x10\^-6 via NGF from BMA) after 1, 2 and 3 years of maintenance therapy.
* Conversion from MRD positive to negative (at sensitivity levels of 10\^-5 and 2x10\^-6 via NGF from BMA).
* Rates of best overall response to treatment (BOR).
* Rates of partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response (sCR).
* Time-to-next-treatment (TTNT).
* PFS on subsequent line of therapy.
* Overall survival (OS).
* Improvement of IMWG response categories (PR, VGPR, CR, sCR).
* Proportions of patients in both treatment arms maintaining BOR and CR from baseline.
* Assessment of quality-of-life (QoL) via the EORTC-QLQC30, EORTC-QLQMY20, and EQ-5D-5L questionnaires.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Iberdomide
36 months of oral iberdomide administration; In cycle 1, dexamethasone is added as pre-medication
Iberdomide
Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)
Dexamethasone
Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)
Arm B: Iberdomide plus isatuximab
36 months of oral iberdomide plus subcutaneous isatuximab administration; In cycle 1, dexamethasone is added as pre-medication
Iberdomide
Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)
Isatuximab
Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)
Dexamethasone
Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iberdomide
Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)
Isatuximab
Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)
Dexamethasone
Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KKS Netzwerk
NETWORK
Wuerzburg University Hospital
OTHER
Sanofi
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
University of Heidelberg Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Elias Mai
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hartmut Goldschmidt, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GMMG-HD9/DSMM XVIII
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.