Clinical trial · Interventional
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After completing Phase 1, the Sponsor elected not to move forward with Phase 2.
Summary
Brief summary (as posted)
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects 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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Finding
- description
- Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
- interventionNames
- Drug: Ibrutinib
- Drug: Pomalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Phase 2: Treatment Arm A
- description
- Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
- interventionNames
- Drug: Ibrutinib
- Drug: Pomalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Phase 2: Treatment Arm B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen. * Measurable disease defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL. 2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine. * Adequate hematologic, hepatic, and renal function * ECOG performance status of ≤ 2 Exclusion Criteria: * Subject must not have primary refractory disease * Plasma cell leukemia, primary amyloidosis or POEMS syndrome * Unable to swallow capsules or disease significantly affecting gastrointestinal function * Requires treatment with strong CYP3A inhibitors * Women who are pregnant or breast feeding.
References
Publications (0)
Data not yet available