Spots Global Cancer Trial Database for Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

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Trial Identification

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

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

Study ID: NCT01676961

Conditions

Refractory Multiple Myeloma

Stage I Multiple Myeloma

Stage II Multiple Myeloma

Stage III Multiple Myeloma

Thrombocytopenia

Interventions

romiplostim

Study Description

Brief 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.