Newly diagnosed symptomatic multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Ruprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).;Secondary Objective: Key secondary objectives (1) Comparison of PRO regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire). (2) Non-inferiority of rates of MRD negativity (assessed by NGS from BMA; sensitivity 10-5) independent of standard IMWG response after induction therapy. Further secondary objectives - Rates of NGS-MRD negativity (sensitivity 10-5, from BMA) independent of standard IMWG response after first HDM/ASCT - Rates of MRD negativity by NGF (sensitivity 10-5, from BMA) independent of standard IMWG response2 after induction therapy - Rates of NGF-MRD negativity (sensitivity 10-5, from BMA) independent of standard IMWG response2 after first HDM/ASCT - Rates of best overall response to treatment (BOR) - Progression-free survival (PFS);Primary end point(s): Rates of VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy;Timepoint(s) of evaluation of this end point: after induction therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints (1) PRO outcomes score assessed by CTSQ (subdomain “satisfaction with therapy”) for SC vs. IV isatuximab application on induction therapy (2) Rates of NGS-MRD negativity (sensitivity 10-5, from BMA) after induction therapy;Timepoint(s) of evaluation of this end point: after induction therapy | — |
Countries
Austria, Germany
Contacts
Public ContactGMMG Studiensekretariat
GMMG Study Office
Outcome results
None listed