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Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

2014-10-01 16:53:23 | BioPortfolio

Summary

This phase II trial studies how well romiplostim works in increasing low platelet counts in patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make platelets after chemotherapy

Description

PRIMARY OBJECTIVES:

I. To determine if Nplate (romiplostim) is capable of increasing platelet counts to > 50 x 10^9/L for greater than 2 weeks in myeloma patients with chemotherapy induced thrombocytopenia.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of romiplostim in this patient population by standard Common Toxicity Criteria (CTC).

II. To determine any increase in thrombosis or marrow fibrosis.

OUTLINE:

Patients receive romiplostim subcutaneously (SC) once weekly for up to 6 weeks. Patients achieving a platelet count > 50 x 10^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Refractory Multiple Myeloma

Intervention

romiplostim

Location

NYU Cancer Institute
New York
New York
United States
10016

Status

Suspended

Source

New York University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-01T16:53:23-0400

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Medical and Biotech [MESH] Definitions

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Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

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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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