Contributions
Abstract: PB1957
Type: Publication Only
Background
Treatment for refractory or relapsed and refractory multiple myeloma (RRMM) remains an unmet need. Isatuximab (ISA), an anti-CD38 monoclonal antibody with multiple mechanisms of tumor killing, has shown efficacy and an acceptable tolerability profile in Phase 1/2 studies in patients with RRMM (Richter et al. ASCO 2016; Vij et al. ASCO 2016; Richardson et al. ASH 2016).
Aims
This Phase III, prospective, multicenter, randomized, open-label study (NCT02990338; ICARIA-MM) is being conducted to evaluate the clinical benefit of ISA in combination with Pom and low-dose dex (Pom/dex) versus Pom/dex for the treatment of adult patients with RRMM.
Methods
Eligible patients are those with RRMM and demonstrated disease progression within 60 days of the last therapy. Patients will have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination. Patients will be randomly assigned in a 1:1 ratio to either ISA (10 mg/kg IV on Days 1, 8, 15, and 22 in the 1st cycle; Days 1 and 15 in subsequent cycles) plus Pom (4 mg on Days 1–21) and dex (at 40 mg for patients <75 years of age and at 20 mg for patients ≥75 years of age, on Days 1, 8, 15, and 22) or Pom and dex. Treatment cycles will be 28 days each. Patients will continue therapy until disease progression, occurrence of unacceptable adverse events (AEs), or their decision to discontinue the study, whichever comes first. All patients will be required to provide informed consent.
Results
Approximately 300 patients (150 in each arm) are expected to be enrolled in this study. Statistical analyses will be conducted according to a pre-specified plan. The first patient was recruited in January 2017.
Conclusion
This Phase III, prospective, multicenter trial will provide a placebo-controlled evaluation of the efficacy and safety of ISA + Pom/dex, a combination which has previously reported preliminary clinical activity and manageable toxicities in heavily pretreated patients with RRMM in a single-arm Phase Ib study.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, CD38
Abstract: PB1957
Type: Publication Only
Background
Treatment for refractory or relapsed and refractory multiple myeloma (RRMM) remains an unmet need. Isatuximab (ISA), an anti-CD38 monoclonal antibody with multiple mechanisms of tumor killing, has shown efficacy and an acceptable tolerability profile in Phase 1/2 studies in patients with RRMM (Richter et al. ASCO 2016; Vij et al. ASCO 2016; Richardson et al. ASH 2016).
Aims
This Phase III, prospective, multicenter, randomized, open-label study (NCT02990338; ICARIA-MM) is being conducted to evaluate the clinical benefit of ISA in combination with Pom and low-dose dex (Pom/dex) versus Pom/dex for the treatment of adult patients with RRMM.
Methods
Eligible patients are those with RRMM and demonstrated disease progression within 60 days of the last therapy. Patients will have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) alone or in combination. Patients will be randomly assigned in a 1:1 ratio to either ISA (10 mg/kg IV on Days 1, 8, 15, and 22 in the 1st cycle; Days 1 and 15 in subsequent cycles) plus Pom (4 mg on Days 1–21) and dex (at 40 mg for patients <75 years of age and at 20 mg for patients ≥75 years of age, on Days 1, 8, 15, and 22) or Pom and dex. Treatment cycles will be 28 days each. Patients will continue therapy until disease progression, occurrence of unacceptable adverse events (AEs), or their decision to discontinue the study, whichever comes first. All patients will be required to provide informed consent.
Results
Approximately 300 patients (150 in each arm) are expected to be enrolled in this study. Statistical analyses will be conducted according to a pre-specified plan. The first patient was recruited in January 2017.
Conclusion
This Phase III, prospective, multicenter trial will provide a placebo-controlled evaluation of the efficacy and safety of ISA + Pom/dex, a combination which has previously reported preliminary clinical activity and manageable toxicities in heavily pretreated patients with RRMM in a single-arm Phase Ib study.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, CD38