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Compassionate Use Study of Carfilzomib

2014-07-23 21:12:23 | BioPortfolio

Summary

This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.

Description

The protocol has been designed for relapsing or refractory multiple myeloma patients. A maximum of 30 patients may be treated on this protocol.

Since this is a compassionate use study of an investigational agent, the size is determined by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment and accrual number will be limited to N=30.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Carfilzomib

Location

University of Arkansas for Medical Sciences
Little Rock
Arkansas
United States
72205

Status

Recruiting

Source

University of Arkansas

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:23-0400

Clinical Trials [1355 Associated Clinical Trials listed on BioPortfolio]

Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function

The purpose of this study is to assess the influence of renal impairment on carfilzomib in subjects with Multiple Myeloma (MM).

Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease

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 ...

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...

A Study of Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety, tolerability and overall response rate of carfilzomib in combination with dexamethasone for the treatment of multiple myeloma in China.

PubMed Articles [5658 Associated PubMed Articles listed on BioPortfolio]

A case of acute liver failure due to carfilzomib in multiple myeloma.

Carfilzomib is a newer drug approved for the treatment of relapsing and refractory multiple myeloma. It has been rarely associated with acute liver failure (ALF).

Proteasome inhibitor-based therapy for treatment of newly diagnosed multiple myeloma.

Multiple myeloma is a hematologic malignancy that is unable to be cured and has significant impact throughout the world. Front line treatment has shifted but ultimately has landed on a bortezomib-base...

Proteasome inhibitors for multiple myeloma.

Therapeutic strategies for multiple myeloma have dramatically changed in the last two decades, especially after the introduction of proteasome inhibitors. The first-in-class proteasome inhibitor, bort...

Carfilzomib-associated cardiovascular adverse events in a non-Caucasian cohort of patients with multiple myeloma: A real-world experience.

Organochlorine Levels in Plasma and Risk of Multiple Myeloma: Organochlorines and risk of multiple myeloma.

To estimate the association between organochlorine pesticides and polychlorinated biphenyls (PCBs) and multiple myeloma (MM).

Medical and Biotech [MESH] Definitions

An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.

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.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

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