Clinical trial · Interventional
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT02939183CI-TRIAL-00081073INTREPID-1completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gastro-Retentive (GR) Formulation | Drug | — | UNRESOLVED |
| Immediate Release (IR) Formulation | Drug | — | UNRESOLVED |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1 Oprozomib Immediate-release (IR) + Dexamethasone
- description
- Oprozomib IR plus dexamethasone
- interventionNames
- Drug: Immediate Release (IR) Formulation
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Part 1 Oprozomib Gastro-retentive (GR) + Dexamethasone
- description
- Oprozomib GR plus dexamethasone
- interventionNames
- Drug: Gastro-Retentive (GR) Formulation
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Part 2 Oprozomib IR + Pomalidomide + Dexamethasone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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. * Other Inclusion Criteria May Apply Exclusion Criteria * Currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s). * Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1; received immunosuppressive therapy within the last 3 months prior to study day 1; having signs or symptoms of acute or chronic graft-versus-host disease. * Autologous stem cell transplant \< 90 days prior to study day 1. * Multiple myeloma with IgM subtype. * POEM syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). * Plasma cell leukemia (\> 2.0 X10\^9/L circulating plasma cells by standard differential). * Waldenstrom's macroglobulinemia. * Other Exclusion Criteria May Apply
References
Publications (0)
Data not yet available
No reference posted for this study.