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A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

2014-08-27 03:40:11 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Multiple Myeloma

Intervention

Palifermin Pre only, placebo, Palifermin Pre and Post

Status

Active, not recruiting

Source

Biovitrum

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:11-0400

Clinical Trials [2235 Associated Clinical Trials listed on BioPortfolio]

Palifermin for the Reduction of Oral Mucositis in Single-Dose Evaluation (PROMISE)

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health ...

Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine wheth...

Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinoc...

Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of pali...

Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle ...

PubMed Articles [11358 Associated PubMed Articles listed on BioPortfolio]

Bisphosphonates for Patients Diagnosed With Multiple Myeloma.

Among patients with multiple myeloma, is bisphosphonate therapy associated with lower rates of mortality, vertebral fractures, nonvertebral fractures, and skeletal-related events compared with placebo...

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).

Severe Cytomegalovirus Enterocolitis Developing following Daratumumab Exposure in Three Patients with Multiple Myeloma.

Survival of multiple myeloma (MM) patients has improved with introduction of novel anti-myeloma agents. Myeloma has transformed into a chronic condition, accompanied with multiple relapses requiring s...

Identification specific miRNA in t(4;14) multiple myeloma based on miRNA-mRNA expressing profile correlation analysis.

Multiple myeloma (MM) is a common malignancy belonging to the hematological system. The translocation t(4;14)(p16.3;q32.3) is a critical cytogenetic change of MM, which is presenting a poor prognosis....

Multiple Myeloma - Current Standards in Surgical Treatment.

Multiple myeloma is a haematological blood cancer in elderly patients, in which neoplastic cell populations cause osteolytic destruction in the bone skeleton. More than 50% of all patients sustain pat...

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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Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...


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