| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02939183 | Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 61 | — | — | Jan 17, 2017 | Oct 6, 2022 | Sep 26, 2024 | 20 | United States, Australia +2 |
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
The MTD was the dose with the highest posterior probability of having a DLT rate within the target toxicity interval (15% to 25%), while the posterior probability of excessive/unacceptable toxicity (\>25% to 100%) is \<40%. DLTs were graded using CTCAE version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment and clinical laboratory tests were recorded as TEAEs.
TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Serious TEAEs were any AE meeting at least 1 of the following criteria: fatal; life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
| Arm | Type | Description |
|---|---|---|
| Part 1 Oprozomib Immediate-release (IR) + Dexamethasone | EXPERIMENTAL | Oprozomib IR plus dexamethasone |
| Part 1 Oprozomib Gastro-retentive (GR) + Dexamethasone | EXPERIMENTAL | Oprozomib GR plus dexamethasone |
| Part 2 Oprozomib IR + Pomalidomide + Dexamethasone | EXPERIMENTAL | Oprozomib IR plus pomalidomide and dexamethasone |
| Part 2 Oprozomib GR + Pomalidomide + Dexamethasone | EXPERIMENTAL | Oprozomib GR plus pomalidomide and dexamethasone |
| Open-label Roll-over | EXPERIMENTAL | Oprozomib GR monotherapy, or oprozomib GR plus dexamethasone |
| Name | Type | Description |
|---|---|---|
| Immediate Release (IR) Formulation | DRUG | Immediate Release (IR) Formulation |
| Gastro-Retentive (GR) Formulation | DRUG | Gastro-Retentive (GR) Formulation |
| Dexamethasone | DRUG | Dexamethasone |
| Pomalidomide | DRUG | Pomalidomide |
Inclusion criteria * Participant must have a pathologically documented, definitively diagnosed, multiple myeloma relapse, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalid...