Relapsed or Relapsed and Refractory Multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - (Part 1) Have relapsed MM after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with Bor/Dex. Subjects must be naive to Bortezomib treatment - (Part 2) Have relapsed MM after receiving a minimum of 1 and a maximum of 3 prior lines of therapy, but not have MM that is refractory to the last treatment, and be eligible for treatment with Bor/Dex. - Have measurable levels of M-component, defined as serum Mcomponent 1.0 g/dL and/or urine M-component 200 mg/24-hour sample. - Be older than or be 18 years of age. - ECOG performance status (0-2). - Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: - Have previously received an allogenic stem cell transplant. - Have received auto SCT within 12 weeks before the first infusion. - Have received chemotherapy or any experimental drug or therapy within 3 weeks before the first infusion. - Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the first infusion. - Have MM that is refractory to bortezomib, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with bortezomib). - Must not be known to be seropositive for HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM;Secondary Objective: • To evaluate the efficacy of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM • To evaluate the pharmacokinetic (PK) profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM;Primary end point(s): Adverse events (AE);Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetic parameters - The rate of response according to the International Uniform Response Criteria. - M-component - Time to progression - Duration of response - Progression free survival.;Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Countries
Denmark, France, Italy, Netherlands, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International N.V.
Outcome results
None listed