Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT01676961
Status:
TERMINATED
Last Update Posted:
2018-10-15
First Post:
2012-08-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy
Sponsor:
NYU Langone Health
Organization:
Study Overview
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
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA016087 | NIH | None | https://reporter.nih.gov/quic… | View |