Phase 1
N=61
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT02939183 ↗Enrolled (actual)
61
Serious AEs
54.2%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Who Experienced Dose-Limiting Toxcity (DLT) — 0; 0; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Immediate Release (IR) Formulation (Drug); Gastro-Retentive (GR) Formulation (Drug); Dexamethasone (Drug); Pomalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxcity (DLT) |
0; 0; 1; 1; 1; 1 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Each Formulation of Oprozomib in Combination With Pomolidomide and Dexamethasone |
250; NA | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Oprozomib in Combination With Dexamethasone and/or Pomalidomide) |
4; 8; 4; 4; 8; 5 | — |
| PRIMARY Number of Participants With TEAEs and Treatment-emergent Serious AEs (Open-label Roll-over) |
7; 4 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Oprozomib |
321; 118; 349; 119; 694; 367 | — |
| SECONDARY Time to Cmax (Tmax) of Oprozomib |
1.0; 2.0; 2.0; 5.8; 2.0; 2.0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Oprozomib |
656; 357; 869; 655; 1210; 1880 | — |
| SECONDARY Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC) |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Overall Response Rate (ORR) According to IMWG-URC |
66.7; 16.7; 33.3; 0.0; 85.7; 60.0 | — |
| SECONDARY Number of Participants With Progression Free Survival (PFS) Events |
0; 1; 1; 0; 0; 2 | — |
| SECONDARY Kaplan-Meier Estimate of PFS |
NA; NA; 14.24; NA; NA; NA | — |
| SECONDARY Kaplan-Meier Estimate of Duration of Response (DOR) |
NA; NA; NA; NA; NA; 16.6 | — |
Summary
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma.
Eligibility Criteria
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 lenalidomide.
- Participant must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
- Measurable disease (assessed within 28 days prior to day 1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 2.0 X10^9/L circulating plasma cells by standard differential).
- Waldenstrom's macroglobulinemia.
- Other Exclusion Criteria May Apply
Data sourced from ClinicalTrials.gov (NCT02939183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.