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Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma

2014-08-27 03:14:52 | BioPortfolio

Summary

RATIONALE: Dinaciclib may stop the growth of cancer cells by clocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well giving dinaciclib works in treating patients with relapsed or refractory multiple myeloma.

Description

OBJECTIVES:

Primary

- To evaluate the efficacy of single agent dinaciclib in patients with relapsed or refractory multiple myeloma.

Secondary

- To evaluate the toxicities associated with dinaciclib in these patients.

- To evaluate the response duration and progression-free survival among these patients.

- To study the effect of dinaciclib on myeloma cell proliferation and apoptotic rates.

- To assess the ability of dinaciclib to inhibit drug targets (cyclin-dependent kinases in the myeloma cell).

OUTLINE: This is a multicenter, dose escalation study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected periodically for correlative studies.

After completion of study treatment, patients are followed up for up to 3 years.

Study Design

Primary Purpose: Treatment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Intervention

dinaciclib, laboratory biomarker analysis

Location

Mayo Clinic Cancer Center
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:52-0400

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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.

A nonproliferative disorder of the PLASMA CELL characterized by excessive production and misfolding of IMMUNOGLOBULIN LIGHT CHAINS that form insoluble amyloid fibrils (see AMYLOID DEPOSITS) in various tissues. Clinical features include LIVER FAILURE; MULTIPLE MYELOMA; NEPHROTIC SYNDROME; RESTRICTIVE CARDIOMYOPATHY, and neuropathies.

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