Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461988
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-11
Brief Title:
Talquetamab Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
An Open-Label Non-Randomized Multicenter Phase II Study to Study the Efficacy of Talquetamab JNJ-64407564 and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma OPTIMMAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Multiple myeloma MM is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM
Detailed Description:
This is a phase 2 study to evaluate the efficacy of talquetamab with a combination of lenalidomide and to determine the safety and longitudinal patient reported symptoms and quality of life
Thirty participants with MM who plan to undergo or who have undergone autologous stem cell transplant as a part of their initial therapy and meet the eligibility criteria will be enrolled in the study
Thirty participants with MM who plan to undergo or who have undergone autologous stem cell transplant as a part of their initial therapy and meet the eligibility criteria will be enrolled in the study
Study Oversight
Has Oversight DMC:
None
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?:
None