Clinical trial · Interventional
Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
NCT02902965CI-TRIAL-00044034completedPhase 2Results 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)
This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibrutinib+ Bortezomib+ Dexamethasone
- interventionNames
- Drug: Ibrutinib
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Median Progression-Free Survival (PFS)
- timeFrame
- The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.
- description
- The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.
Secondary outcomes (6)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with multiple myeloma (MM) who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (Subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use) * Measurable disease defined by at least one of the following: * Serum monoclonal protein (SPEP) ≥1 g/dL (for subjects with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE) or immunoglobulin M (IgM) multiple myeloma SPEP ≥0.5 g/dL) * Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine electrophoresis * Adequate hematologic, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 Exclusion Criteria: * Subject must not have primary refractory disease * Refractory or non-responsive to prior proteasome inhibitor (PI) therapy (bortezomib or carfilzomib) * Peripheral neuropathy Grade ≥2 or Grade 1 with pain at Screening * 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
No reference posted for this study.