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Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
CompletedPhase 3
Sponsor: University of Heidelberg Medical Center
Conditions: Multiple Myeloma
Interventions: Isatuximab, Isatuximab, Lenalidomide, Bortezomib, Dexamethasone
Countries: Austria, Germany
The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.
Eligibility overview
Sex: ALL
Age: 18 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patient has known hypersensitivity (or contraindication) to any of the components of study therapy * Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow) * Plasma cell leukemia * Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression * 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 peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events) * 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 * 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) * Pregnancy and lactation For further details on inclusion/exclusion criteria please refer to the study protocol.
Locations (91)
- Krems, Austria
- Linz, Austria
- Rankweil, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Steyr, Austria
- Vienna, Austria
- Wels, Austria
- Aachen, Germany
- Altona, Germany
- Augsburg, Germany
- Bad Saarow, Germany
- Bayreuth, Germany
- Berlin, Germany
- Berlin, Germany
- Berlin, Germany
- Berlin, Germany
- Bielefeld, Germany
- Bielefeld, Germany
- Bonn, Germany
- Bonn, Germany
- Braunschweig, Germany
- Bremen, Germany
- Chemnitz, Germany
- Cologne, Germany
- Cottbus, Germany
- Darmstadt, Germany
- Dessau, Germany
- Dortmund, Germany
- Dresden, Germany
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