Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments pci-32765, dexamethasone
Phase phase 2
Target BTK
Sponsor Pharmacyclics
Start date March 2012
End date March 2016
Trial size 164 participants
Trial identifier NCT01478581, PCI-32765, PCYC-1111-CA

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PCI-32765 420 mg per day
pci-32765
(Experimental)
PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week
pci-32765
dexamethasone
(Experimental)
PCI-32765 840 mg per day
pci-32765
(Experimental)
PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week
pci-32765
dexamethasone

Primary Outcomes

Measure
Efficacy as defined by clinical benefit rate
time frame: Up to 24 Months

Secondary Outcomes

Measure
To evaluate the efficacy of PCI-32765 by assessing the safety profile
time frame: For 30 days after the last dose of PCI-32765
To evaluate the efficacy of PCI-32765 by assessing the drug pharmacokinetics
time frame: Procedure will be performed during the first month of receiving study drug
Duration of Clinical Benefit Response (DCB)
time frame: Up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of symptomatic MM with measurable disease, defined here as having at least one of the following: 1. Serum monoclonal protein (M-protein) ≥0.5 g/dL as determined by serum protein electrophoresis (SPEP) 2. Urine M-protein ≥200 mg/24 hrs 3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal - Relapsed or relapsed and refractory MM after receiving at least 2 but no more than 5 previous lines of therapy, 1 of which must be an immunomodulator. - Refractory myeloma (to most recent treatment) is defined as disease that is nonresponsive while on treatment or progressive disease within 60 days after the completion of preceding treatment. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy. - Men and women ≥18 years of age. - ECOG performance status of ≤ 1. Exclusion Criteria: - Subject must not have primary refractory disease defined as disease that is nonresponsive in subjects who have never achieved a minor response (MR) or better with any therapy. - Polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome, osteosclerotic myeloma, or Crow-Fukase syndrome. - Plasma cell leukemia. - Primary amyloidosis. - Certain exclusions on prior therapy. - ANC <0.75 x 10^9/L independent of growth factor support. - Platelets <50 x 10^9/L) independent of transfusion support. - AST or ALT ≥3.0 x upper limit of normal (ULN). - Total bilirubin >2.5 x ULN, unless due to Gilbert's syndrome. - Creatinine >2.5 mg/dL. - Unable to swallow capsules or disease significantly affecting gastrointestinal function. - Requires anti-coagulation with warfarin or a vitamin K antagonist. Requires treatment with strong CYP3A4/5 inhibitors.

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Pharmacyclics.