Actively Recruiting
Phase III Study Comparing Iberdomide Alone Versus Iberdomide Plus Isatuximab as Maintenance Therapy After Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Led by University of Heidelberg Medical Center · Updated on 2026-02-02
411
Participants Needed
69
Research Sites
26 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
Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.
CONDITIONS
Brief 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 inclusion and treatment within the GMMG-HD8 / DSMM XIX trial OR received a quadruplet induction/consolidation therapy including a proteasome inhibitor and immunomodulatory drug plus an anti-CD38 antibody
- Post high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT) consolidation containing similar substances as induction therapy is permitted
- Induction and consolidation therapy consist of at least 4 up to 6 cycles, with a maximum of 2 consolidation cycles post HDM/ASCT
- Received at least one cycle of HDM and ASCT
- 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 at inclusion for women of childbearing potential
- Willing and able to use adequate contraception during the entire therapy for men and women of childbearing potential
- Ability to understand the clinical trial and provide written informed consent
You will not qualify if you...
- Gastrointestinal disease that may significantly alter absorption of iberdomide
- Known hypersensitivity or contraindication 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, polyneuropathy, organomegaly, endocrinopathy, or Waldenström macroglobulinemia
- Previous systemic anti-myeloma treatment outside allowed protocols
- Severe cardiac dysfunction (NYHA III-IV)
- Significant hepatic dysfunction unless related to multiple myeloma or HDM/ASCT
- Active or uncontrolled hepatitis B or C, or HIV positivity
- Active, uncontrolled infections
- Severe renal insufficiency (Creatinine Clearance <30 ml/min) or hemodialysis requirement
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- History of active malignancy within 5 years except certain curatively treated 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 multiple 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 breastfeeding
- Severe or uncontrolled medical or psychiatric conditions interfering with study or safety
- Judicial or administrative commitment
- Participation in other interventional clinical trials except defined follow-up periods within past 6 months
Research Team
H
Hartmut Goldschmidt, Prof.
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