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

• Status: Recruiting
• Trial end date: 2026-07-24
• Target enrollment: 0
• Participant gender: All

Summary

The trial aims to demonstrate the non-inferiority of subcutaneos to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multple myeloma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Heidelberg Medical Center
• Collaborators: Deutsche Studiengruppe Multiples Myelom (DSMM); KKS Netzwerk; Sanofi
• Treatments: Antibodies, Monoclonal; Bortezomib; Dexamethasone; Lenalidomide

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.