Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

Prior treatment

• Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression

Other illness

• Patient has known hypersensitivity (or contraindication) to any of the components of study therapy
• Severe cardiac dysfunction (NYHA classification III-IV)
• Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C
• HIV positivity
• Patients with active, uncontrolled infections
• Patients with severe renal insufficiency or requiring hemodialysis
• 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

Lab values

• Platelet count \< 75 x 10\^9/L
• Haemoglobin ≤ 8.0 g/dL, unless related to MM
• Absolute neutrophil count (ANC) \< 1.0 x 10\^9/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)

Other

• Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow)
• Plasma cell leukemia
• Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events)
• Pregnancy and lactation
  • For further details on inclusion/exclusion criteria please refer to the study protocol.

• Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG)
• Patient is eligible for high-dose melphalan (200 mg/m\^2 melphalan) and autologous stem cell transplantation
• Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24 hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
• Age 18-70 years at trial inclusion