Multiple myeloma MedDRA version: 18.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Intergroupe Francophone du Myelome (IFM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - diagnosis of previously untreated multiple myeloma (MM) - have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 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 1060 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - previous treatment for Multiple Myeloma - Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma - Prior or concurrent exposure to systemic therapy or SCT for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1 - history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix - known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma - any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma. ;Secondary Objective: -Progression-free survival (PFS) from first randomization -Time to progression (TTP) -Post-ASCT/ consolidation CR rate -Post-ASCT/consolidation MRD negative rate -Post-induction sCR rate -PFS2 (from first randomization) -OS (from first randomization);Primary end point(s): 1. The percentage of participants who achieve a stringent complete response (sCR) after consolidation therapy 2. The percentage of increase in progression free survival after maintenance therapy;Timepoint(s) of evaluation of this end point: Up to 9 months for point 1. Up to 60 months for point 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PFS (from first randomization) 2.Time to progression (TTP) 3.Post-ASCT/ consolidation CR rate 4.Post-ASCT/consolidation MRD negative rate 5.Post-induction sCR rate 6.PFS2 (from first randomization) 7.OS (from first randomization);Timepoint(s) of evaluation of this end point: points 1, 2, 6, 7 - Up to 60 months points 3, 4 - Up to 9 months point 5 - Up to 4 months | — |
Countries
Belgium, France, Netherlands
Contacts
Public ContactMarie-Lou Camut
Axonal
Outcome results
None listed