Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02072863 | A Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma | PHASE1 | COMPLETED | 9 | — | — | Jan 1, 2014 | Sep 1, 2015 | May 2, 2017 | 8 | Greece, Italy +1 |
MTD is defined as the highest dose at which a DLT is observed in less than 2 of 6 evaluable subjects occurring within the 4 weeks after the first dose of combination therapy.
ORR defined as a best overall response of sCR, CR, VGPR, or PR according to the IMWG-URC.
CRR defined as a best overall response of sCR or CR according to the IMWG-URC.
| Arm | Type | Description |
|---|---|---|
| Oprozomib with Melphalan and Prednisone (OMP) | EXPERIMENTAL | Subjects will receive oprozomib administered orally. The combination of oprozomib, melphalan, and prednisone (OMP) will be administered until progression of disease, unacceptable toxicity, discontinuation of study treatment for reasons other than progression or toxicity, or a maximum of 9 cycles (54 weeks), whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Oprozomib | DRUG | Study subjects will receive oprozomib administered orally. |
| Melphalan | DRUG | Study subjects will receive melphalan 9 mg/m2. |
| Prednisone | DRUG | Study subjects will receive prednisone 60 mg/m2. |
Key Inclusion Criteria: 1. Newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following: 1. Serum M-protein ≥ 500 mg/dL 2. Urine M-protein ≥ 200 mg/24 hour 3. Serum Free Light Chain: Involved free...