Multiple myeloma MedDRA version: 19.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Daratumumab
Product Code: HuMax-CD38-Phase 1/2 Drug
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Daratumumab
CAS Number: 945721-28-2
Current Sponsor co
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented diagnosis of multiple myeloma requiring systemic therapy 2. Age = 18 years. 3. ECOG performance status (0-2). 4. Life expectancy > 3 months. 5. Relapsed or refractory to two or more different prior therapies 6. 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Plasma cell leukemia defined as a plasma cell count > 2000/mm3. 2. Known amyloidosis 3. Patients who previously have received an allogenic stem cell transplant and receive or have received immunosuppressive therapy within the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety profile of daratumumab when given as monotherapy in patients with multiple myeloma relapsed or refractory to at least 2 different cytoreductive therapies and without further established treatment options.;Secondary Objective: • To establish the pharmacokinetic profile of HuMax-CD38 after single and multiple infusions. • To evaluate the efficacy of daratumumab when given as monotherapy in patients with multiple myeloma who are relapsed or refractory to at least 2 different cytoreductive therapies and without further established treatment options. • To establish safe dose levels for future studies with daratumumab. • To evaluation the immunogenicity of daratumumab. • To optimize premedication adn infusion parameters for daratumumab • To evaluate biomarkers of daratumumab´s mechanism of action, infusion reactions, and clinical response;Primary end point(s): Adverse events (AE);Timepoint(s) of evaluation of this end point: 6 months after the Cycle 1 Day 1 dose of the last patient. 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 - Objective response - M-component - Time to progression - Duration of response - Survival;Timepoint(s) of evaluation of this end point: 6 months after the Cycle 1 Day 1 dose of the last patient. At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Countries
Denmark, Netherlands, Sweden, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International N.V.
Outcome results
None listed