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Clinical Trials in Germany / NCT06216158
Active, not recruiting Phase 3

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

NCT06216158 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2024-04-05
Last updated
2026-08-17

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Iberdomide →Isatuximab →Dexamethasone →

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)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
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

+ 29 more sites — see the full list on the official registry below.

More University of Heidelberg Medical Center trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06216158 on ClinicalTrials.gov ↗ ← All trials in Germany