Advertisement

Topics

Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

2014-08-27 03:26:56 | BioPortfolio

Summary

RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.

Description

OBJECTIVES:

Primary

- To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexamethasone added for disease progression or lack or partial response.

Secondary

- To assess the response rate of this regimen in these patients.

- To assess the toxicity of this regimen in these patients.

Tertiary

- To examine the effect of lenalidomide alone on tumor specific immunity and global parameters of immune function.

- To examine the effect of dexamethasone addition in patients requiring steroids.

- To correlate changes in parameters of immune response and measures of disease response.

- To examine the antiangiogenic activity of lenalidomide alone and in combination with dexamethasone.

- To examine the effect of lenalidomide alone on tumor cell survival and proliferation.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of second disease progression or unacceptable toxicity. Beginning in course 4, patients experiencing stable or progressive disease also receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all subsequent courses.

Blood and bone marrow samples are collected periodically for pharmacological and correlative studies. Samples are analyzed for parameters of immune activation, cell proliferation and apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via CD34 staining.

After completion of study therapy, patients are followed periodically for up to 2 years.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Intervention

dexamethasone, lenalidomide, flow cytometry, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, staining method, bone marrow aspiration

Location

Mayo Clinic Cancer Center
Rochester
Minnesota
United States
55905

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:56-0400

Clinical Trials [2529 Associated Clinical Trials listed on BioPortfolio]

Ketoconazole, Hydrocortisone, and Lenalidomide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of pros...

Bevacizumab, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Stage II or Stage III Multiple Myeloma

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and he...

Lenalidomide and CCI-779 in Treating Patients With Previously Treated Multiple Myeloma

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth...

Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well lenalidomide works...

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to...

PubMed Articles [15828 Associated PubMed Articles listed on BioPortfolio]

A Novel Rapid Method of Red Blood Cell and Platelet Permeabilization and Staining for Flow Cytometry Analysis.

Flow cytometry essentially focuses on surface-expressed proteins, with few protocols being devoted to intracellular components. We evaluated a two-step procedure using new formaldehyde-free permeabili...

Evaluation of Mass Cytometry in the Clinical Laboratory.

Mass cytometry can differentiate more channels than conventional flow cytometry. However, for clinical use, standardization and agreement with well-established methods is paramount. We compared mass c...

Evaluation of an Alternative Staining Method Using SYTO 13 to Determine Reticulated Platelets.

Reticulated platelets reflect the rate of platelet turnover and represent the youngest circulating platelets in peripheral blood. Reticulated platelets contain residual ribonucleic acid (RNA) from meg...

Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma.

Lenalidomide plus dexamethasone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. We sought to determine whether t...

Usefulness of Flow Cytometry for the Detection of Cutaneous Localization in Malignant Hematologic Disorders.

Histological evaluation of malignant hematologic involvement of the skin can be challenging and needs an extended immunohistochemistry panel. We assessed the ability of flow cytometry (FCM) to detect ...

Medical and Biotech [MESH] Definitions

A technique encompassing morphometry, densitometry, neural networks, and expert systems that has numerous clinical and research applications and is particularly useful in anatomic pathology for the study of malignant lesions. The most common current application of image cytometry is for DNA analysis, followed by quantitation of immunohistochemical staining.

Process of classifying cells of the immune system based on structural and functional differences. The process is commonly used to analyze and sort T-lymphocytes into subsets based on CD antigens by the technique of flow cytometry.

A group of cells identified on FLOW CYTOMETRY profiles as distinct from the main group of cells by their ability to extrude the fluorescent dye Hoechst 33342, often a characteristic property of less differentiated progenitor and STEM CELLS.

Measurement of light given off by fluorescein in order to assess the integrity of various ocular barriers. The method is used to investigate the blood-aqueous barrier, blood-retinal barrier, aqueous flow measurements, corneal endothelial permeability, and tear flow dynamics.

JAUNDICE, the condition with yellowish staining of the skin and mucous membranes, that is due to impaired BILE flow in the BILIARY TRACT, such as INTRAHEPATIC CHOLESTASIS, or EXTRAHEPATIC CHOLESTASIS.

More From BioPortfolio on "Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Immunology
Allergies Automimmune Disease Human Papillomavirus (HPV) Immunology Vaccine Immunology is the study of immunity and the defence mechanisms of the body. A greater understanding of immunology is needed to develop vaccines, understand ...


Searches Linking to this Trial