Phase 2
Completed N=74
Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT02902965 ↗Enrolled (actual)
74
Serious AEs
63.5%
Results posted
Jan 2020
Primary outcomePrimary: Median Progression-Free Survival (PFS) — 8.5 Months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-Free Survival (PFS) |
8.5 | — |
| SECONDARY Overall Response Rate (ORR) |
56.8 | — |
| SECONDARY Progression Free Survival (PFS) at Landmark Points - 20 Months |
6.6 | — |
| SECONDARY Duration of Response (DOR) |
9.5 | — |
| SECONDARY Overall Survival (OS) at 24 Months |
53.6 | — |
| SECONDARY Time to Progression (TTP) |
10.6 | — |
| SECONDARY Safety and Tolerability of Ibrutinib in Combination With Bortezomib and Dexamethasone as Measured by the Number of Participants With Adverse Events. |
74 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02902965). 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. Informational only — not medical advice.