Actively Recruiting
Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
Led by University of Heidelberg Medical Center · Updated on 2026-02-02
411
Participants Needed
69
Research Sites
269 weeks
Total Duration
On this page
Sponsors
U
University of Heidelberg Medical Center
Lead Sponsor
K
KKS Netzwerk
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior participation and treatment within the GMMG-HD8 / DSMM XIX trial OR received a quadruplet induction/consolidation therapy including a proteasome inhibitor, immunomodulatory drug, and an anti-CD38 monoclonal antibody
- Post high dose melphalan (HDM) and autologous stem cell transplantation (ASCT) consolidation therapy permitted
- Total induction and consolidation therapy of at least 4 and up to 6 cycles, with a maximum of 2 post-ASCT consolidation cycles
- Received at least one cycle of HDM and ASCT
- Achieved at least Partial Response (PR) according to IMWG criteria at trial inclusion
- Age 18 years or older at trial inclusion
- WHO performance status of 0, 1, or 2
- Negative pregnancy test for women of childbearing potential
- Willing and capable of using adequate contraception if of childbearing potential
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Gastrointestinal disease affecting absorption of iberdomide
- Known hypersensitivity or intolerance to study therapy components not manageable by premedication
- History of serious allergic reaction to immunomodulatory agents like thalidomide, lenalidomide, or pomalidomide
- Current treatment with strong CYP3A4/5 inhibitors or inducers
- Systemic AL amyloidosis, plasma cell leukemia, or related disorders
- Previous systemic anti-myeloma treatment outside defined criteria
- Severe cardiac dysfunction (NYHA III-IV)
- Significant liver dysfunction unless related to myeloma or therapy
- Active or uncontrolled hepatitis B or C infection without adequate prophylaxis
- HIV positivity
- Active, uncontrolled infections
- Severe renal insufficiency or need for hemodialysis
- Peripheral neuropathy grade 2 or higher
- History of active malignancy within past 5 years except certain cured cancers
- Acute diffuse infiltrative pulmonary or pericardial disease
- Autoimmune hemolytic anemia or immune thrombocytopenia
- Platelet count below 75 x 10^9/l
- Hemoglobin 8.0 g/dl or less unless related to myeloma
- Absolute neutrophil count below 1.0 x 10^9/l
- Corrected serum calcium above 14 mg/dl
- Unable or unwilling to undergo thromboprophylaxis
- Pregnancy or lactation
- Any severe or uncontrolled medical or psychiatric condition interfering with study
- Judicial or administrative commitment to an institution
- Participation in other interventional clinical trials except certain follow-up periods within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
Universitätsklinikum Krems an der Donau
Krems, Austria, 3500
Actively Recruiting
2
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Actively Recruiting
3
Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Actively Recruiting
4
Klinik Ottakring Wien
Vienna, Austria, 1160
Actively Recruiting
5
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Actively Recruiting
6
Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Aachen, Germany, 52074
Actively Recruiting
7
Universitätsklinikum
Augsburg, Germany, 86156
Actively Recruiting
8
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
Actively Recruiting
9
Charité, III. Medizinische Abteilung
Berlin, Germany, 12200
Actively Recruiting
10
Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie
Berlin, Germany, 12351
Actively Recruiting
11
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
12
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, 33604
Actively Recruiting
13
Evangelisches Klinikum Bethel
Bielefeld, Germany, 33611
Actively Recruiting
14
Johanniter Krankenhaus
Bonn, Germany, 53113
Actively Recruiting
15
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
16
Städtisches Klinikum
Braunschweig, Germany, 38114
Actively Recruiting
17
Klinikum Chemnitz
Chemnitz, Germany, 09116
Actively Recruiting
18
Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik
Cottbus, Germany, 03048
Actively Recruiting
19
Klinikum Darmstadt GmbH, Medizinische Klinik V
Darmstadt, Germany, 64283
Actively Recruiting
20
Städtisches Klinikum
Dessau, Germany, 06847
Actively Recruiting
21
St. Johannes Hospital Dortmund
Dortmund, Germany, 44137
Not Yet Recruiting
22
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
23
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
24
Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatalogie und Palliativmedizin
Düsseldorf, Germany, 40479
Actively Recruiting
25
St. Antonius-Hospital
Eschweiler, Germany, 52249
Actively Recruiting
26
KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
Essen, Germany, 45239
Actively Recruiting
27
Malteser Krankenhaus
Flensburg, Germany, 24939
Actively Recruiting
28
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
29
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Germany, 60389
Actively Recruiting
30
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
31
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Actively Recruiting
32
Katholisches Krankenhaus Hagen
Hagen, Germany, 58097
Actively Recruiting
33
Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie
Hamburg, Germany, 20246
Actively Recruiting
34
Asklepios Klinik Altona
Hamburg, Germany, 22763
Actively Recruiting
35
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
36
Onkologische Schwerpunktpraxis
Heidelberg, Germany, 69115
Actively Recruiting
37
Universitätsklinikum Heidelberg, Medizinische Klinik V
Heidelberg, Germany, 69120
Actively Recruiting
38
SLK Kliniken Heilbronn, Medizinische Klinik III
Heilbronn, Germany, 74078
Actively Recruiting
39
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1
Homburg, Germany, 66421
Actively Recruiting
40
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie
Jena, Germany, 07740
Actively Recruiting
41
Westpfalz-Klinikum
Kaiserslautern, Germany, 67655
Actively Recruiting
42
Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie
Kempten, Germany, 87439
Actively Recruiting
43
Gemeinschaftsklinikum Mittelrhein Koblenz
Koblenz, Germany, 56073
Actively Recruiting
44
Oncocare, Gemeinschaftspraxis für Hämatologie und Onkologie
Lebach, Germany, 66822
Not Yet Recruiting
45
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063
Actively Recruiting
46
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
47
Universitätsmedizin der Johannes Gutenberg-Universität
Mainz, Germany, 55131
Actively Recruiting
48
Universitätsklinikum Mannheim, III. Medizinische Klinik
Mannheim, Germany, 68167
Actively Recruiting
49
Onkologie Praxis
Mannheim, Germany, 69161
Actively Recruiting
50
Philipps-Universität Marburg Hämatologie/Onkologie
Marburg, Germany, 35043
Actively Recruiting
51
Klinikum Hochsauerland
Meschede, Germany, 59870
Actively Recruiting
52
Kliniken Maria Hilf
Mönchengladbach, Germany, 41063
Actively Recruiting
53
Kliniken Ostalb
Mutlangen, Germany, 73557
Actively Recruiting
54
Rotkreuzklinikum
München, Germany, 80634
Actively Recruiting
55
Klinikum rechts der Isar der TU München
München, Germany, 81675
Actively Recruiting
56
Klinikum Oldenburg
Oldenburg, Germany, 26133
Actively Recruiting
57
Klinikum Osnabrück GmbH
Osnabrück, Germany, 49076
Actively Recruiting
58
Brüderkrankenhaus St. Josef
Paderborn, Germany, 33098
Actively Recruiting
59
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
Regensburg, Germany, 93049
Actively Recruiting
60
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
61
Diakoneo Diak Klinikum
Schwäbisch Hall, Germany, 74523
Actively Recruiting
62
ZAHO - Zentrum für ambulante Hämatologie und Onkologie
Siegburg, Germany, 53721
Actively Recruiting
63
Onkologische Schwerpunktpraxis Speyer
Speyer, Germany, 67346
Actively Recruiting
64
Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital
Stuttgart, Germany, 70174
Actively Recruiting
65
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Actively Recruiting
66
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
67
Universitätsklinikum
Ulm, Germany, 89081
Actively Recruiting
68
Schwarzwald Baar Klinikum
Villingen-Schwenningen, Germany, 78052
Actively Recruiting
69
University of Würzburg, Med. Klinik und Poliklinik II
Würzburg, Germany, 97080
Actively Recruiting
Research Team
H
Hartmut Goldschmidt, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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