Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT05145816
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2021-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Status:
RECRUITING
Status Verified Date:
2025-11
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 goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and amyloidosis, and to determine the most effective dose of the drug.
The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1
The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1
Detailed Description:
Amyloid light chain amyloidosis (AL amyloidosis, ALA) is a rare plasma cell dyscrasia with an incidence ranging from 9.7-14.0 cases per million person-years. 75% of patients have cardiac involvement at diagnosis as evaluated by plasma cardiac biomarkers. The most common cause of morbidity and mortality is cardiac dysfunction.
Belantamab mafodotin has not been evaluated previously in patients with AL amyloidosis. Although Belantamab mafodotin has previously been or is currently being evaluated in patients with relapsed multiple myeloma (MM), these MM studies do not enroll participants with clinically significant cardiac dysfunction.
ALA represents a new patient population and therapeutic indication where patients invariably will have clinically significant cardiac, renal or other organ dysfunction at study enrollment. Therefore, the Phase I/IIa RRAL study will be comprised of two parts:
Part 1 - Dose Exploration (Escalation) this will be conducted to identify and select an appropriate dose of Belantamab mafodotin in regard to safety, as well as a preliminary evaluation of hematological and organ response. Part 1 will enroll a minimum of 3 to maximum of 18 patients, per dose cohort, and will be guided using the Bayesian optimal interval (BOIN) design.
Part 2 - Dose Cohort Expansion this will be an expansion cohort to further define the depth and durability of both hematological and organ response in 19 additional patients for a total of up to 37 patients.
Belantamab mafodotin has not been evaluated previously in patients with AL amyloidosis. Although Belantamab mafodotin has previously been or is currently being evaluated in patients with relapsed multiple myeloma (MM), these MM studies do not enroll participants with clinically significant cardiac dysfunction.
ALA represents a new patient population and therapeutic indication where patients invariably will have clinically significant cardiac, renal or other organ dysfunction at study enrollment. Therefore, the Phase I/IIa RRAL study will be comprised of two parts:
Part 1 - Dose Exploration (Escalation) this will be conducted to identify and select an appropriate dose of Belantamab mafodotin in regard to safety, as well as a preliminary evaluation of hematological and organ response. Part 1 will enroll a minimum of 3 to maximum of 18 patients, per dose cohort, and will be guided using the Bayesian optimal interval (BOIN) design.
Part 2 - Dose Cohort Expansion this will be an expansion cohort to further define the depth and durability of both hematological and organ response in 19 additional patients for a total of up to 37 patients.
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?: