Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-06 @ 6:19 PM
Study NCT ID:
NCT00437034
Status:
TERMINATED
Last Update Posted:
2021-02-08
First Post:
2007-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aflibercept for Relapsed Multiple Myeloma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of Aflibercept for the Treatment of Relapsed or Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
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 is studying the side effects and how well aflibercept works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment. Aflibercept may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.
Detailed Description:
OBJECTIVES:
I. To evaluate the safety and efficacy of VEGF Trap (aflibercept) in patients with relapsed or refractory, stage II or III multiple myeloma (MM).
II. To perform correlative studies in order to evaluate the angiogenic properties of tissue from patients during the course of treatment with VEGF Trap.
OUTLINE: This is a multicenter study.
Patients receive aflibercept intravenously (IV) over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 60 days and then periodically thereafter.
I. To evaluate the safety and efficacy of VEGF Trap (aflibercept) in patients with relapsed or refractory, stage II or III multiple myeloma (MM).
II. To perform correlative studies in order to evaluate the angiogenic properties of tissue from patients during the course of treatment with VEGF Trap.
OUTLINE: This is a multicenter study.
Patients receive aflibercept intravenously (IV) over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 60 days and then periodically thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| NCI-2009-00181 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 0608008688 | OTHER | Montefiore Medical Center | View | |
| 7521 | OTHER | CTEP/NCI | View | |
| P30CA013330 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62204 | NIH | None | https://reporter.nih.gov/quic… | View |