Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Trial Evaluating the Efficacy and Safety of Romiplostim (Nplate) Treatment of Chemotherapy Induced Thrombocytopenia in Patients With Multiple Myeloma|
- Percentage of patients who have responded [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.
- Percentage of patients who experienced thrombosis or marrow fibrosis [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (romiplostim)
Patients receive romiplostim 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..
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676961
|United States, New York|
|NYU Cancer Institute|
|New York, New York, United States, 10016|
|Principal Investigator:||Amitabha Mazumder||New York University School of Medicine|