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?
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
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
Parallel
Iberdomide
DrugIberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)
Isatuximab
DrugIsatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)
Dexamethasone
DrugDexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)
Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD).
The primary objective of this trial is to compare the two-year MRD negativity rate (sensitivity 2x10\^-6 via next-generation flow cytometry \[NGF\]; from bone marrow aspirate) when treated with iberdomide plus isatuximab, with the MRD negativity after treatment with iberdomide only.
Progression-free survival (PFS) from date of randomization.
PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.
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University of Heidelberg Medical Center
Lead sponsor
KKS Netzwerk
Collaborator
Wuerzburg University Hospital
Collaborator
Sanofi
Collaborator
Bristol-Myers Squibb
Collaborator
