Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy
|ClinicalTrials.gov Identifier: NCT01676961|
Recruitment Status : Terminated (PI left the institution)
First Posted : August 31, 2012
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Thrombocytopenia||Biological: romiplostim||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2013|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
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..
- Percentage of Patients Who Have Responded [ Time Frame: 8 weeks ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|