Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
Study NCT ID:
NCT05344833
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2025-05
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:
HEME-18
Brief Summary:
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Detailed Description:
This is a phase II study where patients will undergo isatuximab and lenalidomide-based maintenance if they are MRD-positive after ASCT. Patients may have received equal to or less than 2 lines of induction therapy prior to ASCT. Patients will be enrolled at any time prior to ASCT or up to day 180 after ASCT.Patients will undergo disease reassessment per standard of care including BM examination and MRD testing by NGS at day 90 (+/- 30 days) of ASCT. All patients in MRD-negative (defined as 10-6) CR will be treated off study with lenalidomide monotherapy and all patients who are MRD-positive will begin treatment with isatuximab and lenalidomide, starting any time after MRD results are obtained (treatment must commence before day 180 of ASCT).Patients will be monitored for disease response and every 12 months for BM MRD status, for a total of 3 years, or until disease progression or unacceptable toxicity meeting criteria for protocol removal.
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?:
False
Is an FDA AA801 Violation?: