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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02902965 |
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Date of registration:
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19/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma
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Scientific title:
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An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma |
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Date of first enrolment:
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September 20, 2016 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02902965 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Czechia
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Germany
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Greece
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Italy
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Poland
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Spain
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Turkey
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Contacts
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Name:
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Bernhard Hauns, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pharmacyclics Switzerland GmbH |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: Bortezomib
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Drug: Ibrutinib
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Drug: Dexamethasone
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Primary Outcome(s)
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Median Progression-Free Survival (PFS)
[Time Frame: 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.]
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Secondary Outcome(s)
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Safety and Tolerability of Ibrutinib in Combination With Bortezomib and Dexamethasone as Measured by the Number of Participants With Adverse Events.
[Time Frame: From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).]
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Overall Response Rate (ORR)
[Time Frame: The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Overall Response (OR) during the entire time on the study.]
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Duration of Response (DOR)
[Time Frame: The median time on study was 19.6 months (range: 0.16+, 24.64).]
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Overall Survival (OS) at 24 Months
[Time Frame: The median time on study was 19.6 months (0.16+, 24.64), with the 24 month Overall Survival (OS) rate presented based on Kaplan-Meier estimates.]
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Time to Progression (TTP)
[Time Frame: The median time on study was 19.6 months (range: 0.16+, 24.64).]
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Progression Free Survival (PFS) at Landmark Points - 20 Months
[Time Frame: The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.]
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Secondary ID(s)
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PCYC-1139-CA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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