NCT01676961

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma
• Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	romiplostim	Given SC

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-08-31
• Last updated: 2018-10-15
• Results posted: 2017-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study