Trials / Completed
CompletedNCT01478581
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)
Detailed description
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. PCI 32765 is a potent and specific inhibitor of Btk currently in Phase 2 clinical trials. The current study is designed and intended to determine the effects of PCI-32765 in subjects with MM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PCI-32765 | |
| DRUG | Dexamethasone |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2011-11-23
- Last updated
- 2020-03-10
- Results posted
- 2018-06-26
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01478581. Inclusion in this directory is not an endorsement.