Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease
Summary
The purpose of this study is to expand upon the safety data for carfilzomib by providing expanded access to patients with relapsed and refractory multiple myeloma who are unable to enroll in any other ongoing carfilzomib trial.
Description
This is a multi-center, expanded access, open label study of carfilzomib for patients with relapsed and refractory multiple myeloma. The study is designed to provide access to patients with relapsed and refractory disease that have received at least 4 prior regimens and are not eligible for any other enrolling carfilzomib Onyx-sponsored studies enrolling patients in the United States.
Study Design
N/A
Conditions
Multiple Myeloma
Intervention
Carfilzomib
Status
Approved for marketing
Source
Onyx Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01410500
- Information obtained from ClinicalTrials.gov on September 10, 2012
Medical and Biotech [MESH] Definitions
Leukemia, Plasma Cell
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Myeloma Proteins
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Bence Jones Protein
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
Hla-c Antigens
Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).
Multiple Myeloma
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
Clinical Trials
Compassionate Use Study of Carfilzomib
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
The purpose of this study is to assess the influence of renal impairment on carfilzomib in subjects with Multiple Myeloma (MM).
Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma
Approximately 155 evaluable subjects with relapsed multiple myeloma will be enrolled to evaluate the best overall response rate, safety and tolerability of carfilzomib in this phase 2 stud...
Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
250 evaluable subjects with relapsed and refractory multiple myeloma will be enrolled to evaluate the overall response rate and safety and tolerability of carfilzomib in this phase 2 study...
This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myelom...
PubMed Articles
Carfilzomib in multiple myeloma patients with renal impairment: pharmacokinetics and safety.
This phase 2 study assessed the safety, pharmacokinetics, pharmacodynamics, and efficacy of carfilzomib, a selective proteasome inhibitor, in patients with multiple myeloma and varying degrees of rena...
Carfilzomib: a next-generation proteasome inhibitor for multiple myeloma treatment.
Although the incidence of multiple myeloma (MM) is increasing, the median overall survival and the number of agents in the pipeline for treating MM also are increasing. Response rates higher than 80%...
Several cytogenetic abnormalities are associated with poor outcomes in multiple myeloma (MM). We prospectively analyzed the impact of cytogenetic abnormalities on outcomes during the phase 2 PX-171-00...
Proteasomes degrade the majority of proteins in mammalian cells by a concerted action of three distinct pairs of active sites. The chymotrypsin-like sites are targets of antimyeloma agents bortezomib...
Abstract Multiple myeloma is a common hematological malignancy that urgently requires new approaches to treatment since the disease is not curable using current chemotherapeutic regimens. The aim of t...
