Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT03375567
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone (CRD)
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.
Detailed Description:
Carfilzomib, lenalidomide and dexamethasone (CRD) combination therapy is generally associated with high response rates. The expectation is that induction therapy with CRD will result in responses within the myeloma lesions. Extrapolating from the published experience on standard bone marrow response rates with CRD regimen, it is predicted that guided biopsy of myeloma lesions will reveal VGPR/CR/nearCR rate up to 50%. Further, it can be hypothesized that myeloma lesion biopsy will increase the detection rate of residual/refractory disease by about 20%, as compared with standard bone marrow evaluation. Thus, it is expected that myeloma lesion biopsy response rate may be discordant from the standard bone marrow response rate. The identification of patients with large residual disease burden in the myeloma lesions will indicate the need for further salvage therapy. Based on this, it is expected that advanced imaging with guided myeloma lesion biopsy will result in significantly improved response assessment strategy after induction therapy, and will allow better selection of patients prior to autologous stem cell transplant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: