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

Inclusion Criteria31

• 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)
• 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.