Trial in patients with newly diagnosed myeloma to assess non-inferiority of induction therapy with isatuximab/lenalidomide/ bortezomib/ dexamethasone when isatuximab is administered subcutaneously versus intravenously

Phase 1

Conditions: ewly diagnosed symptomatic multiple myeloma
MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2022-000996-38-AT

Lead Sponsor: Ruprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 514

Inclusion Criteria

- Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG)
- Patient is eligible for HDM (200 mg/m2 melphalan) and ASCT
- 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
- Serum FLC assay: involved FLC level = 10 mg/dL provided sFLC ratio is abnormal
- Age 18-70 years at trial inclusion
- WHO performance status 0-2
- Negative pregnancy test at inclusion in 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
- All patients must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 412
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

- Systemic AL amyloidosis
- Plasma cell leukemia
- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression.
- Severe cardiac dysfunction
- Significant hepatic dysfunction
- 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
- 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.