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

Thrombocytopenia Clinical Trial

Official title: Phase II Trial Evaluating the Efficacy and Safety of Romiplostim (Nplate) Treatment of Chemotherapy Induced Thrombocytopenia in Patients With Multiple Myeloma

Status Terminated

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma
• Thrombocytopenia

• NCT number: NCT01676961
• Study type: Interventional
• Source: New York University School of Medicine
• Status: Terminated
• Phase: Phase 2
• Start date: January 2013
• Completion date: November 2015