Relapsed or Refractory Multiple Myeloma (RRMM) Diffuse Large B Cell Lymphoma (DLBCL) Acute Myeloid Leukemia (AML)
Conditions
Brief summary
- Incidence of DLTs, - Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, electrocardiograms (ECGs), - Tolerability: Dose interruptions, delay, and dose intensity. Please refer to the protocol section 3 (Tables 3-2 and 3-3) for the full list of primary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
Detailed description
• Noncompartmental PK parameters (if feasible): o Maximum concentration (Cmax) o Time to Cmax (Tmax) o Predose concentration (Ctrough) o Area under the concentration-time curve from time zero to last quantifiable sample (AUC0-last) and from time zero to 168 h (AUC0- 168h) o Accumulation ratios in Cmax (RA,Cmax) and AUC (RA,AUC]. In addition, a population PK modeling approach may be employed., • Anti-GEN3014 antibodies • Objective response rate (ORR) • Clinical benefit rate (CBR) • Duration of response (DOR) • Time-to-response (TTR), • Progression-free survival (PFS) • Overall survival (OS).Please refer to the protocol section 3 (Tables 3-2 and 3-3) for the full list of secondary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively.
Interventions
DRUGGEN3014 DP
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of DLTs, - Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, electrocardiograms (ECGs), - Tolerability: Dose interruptions, delay, and dose intensity. Please refer to the protocol section 3 (Tables 3-2 and 3-3) for the full list of primary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Noncompartmental PK parameters (if feasible): o Maximum concentration (Cmax) o Time to Cmax (Tmax) o Predose concentration (Ctrough) o Area under the concentration-time curve from time zero to last quantifiable sample (AUC0-last) and from time zero to 168 h (AUC0- 168h) o Accumulation ratios in Cmax (RA,Cmax) and AUC (RA,AUC]. In addition, a population PK modeling approach may be employed., • Anti-GEN3014 antibodies • Objective response rate (ORR) • Clinical benefit rate (CBR) • Duration of response (DOR) • Time-to-response (TTR), • Progression-free survival (PFS) • Overall survival (OS).Please refer to the protocol section 3 (Tables 3-2 and 3-3) for the full list of secondary endpoints for the Expansion Part A (GEN3014 Single Cohorts) and Expansion Part B (Randomized H2H) of the study, respectively. | — |
Countries
Czechia, Denmark, Greece, Hungary, Poland, Spain, Sweden
Outcome results
None listed