Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04956302
Status:
TERMINATED
Last Update Posted:
2024-06-06
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
Sponsor:
Abdullah Khan
Organization:
Study Overview
Official Title:
A Phase I Study of Panobinostat in Combination With Daratumumab, Bortezomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the possible benefits and side effects of adding panobinostat to a combination of daratumumab, bortezomib and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory). Panobinostat may stop or slow multiple myeloma by blocking the growth of new blood vessels necessary for cancer growth. Giving panobinostat in combination with daratumumab, bortezomib and dexamethasone may work better in treating relapsed/refractory multiple myeloma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of Farydak (panobinostat lactate)/Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Velcade (bortezomib)/dexamethasone (FDVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have previously received one line of therapy including lenalidomide or cyclophosphamide, bortezomib (V) or other proteasome inhibitor (PI), with or without autologous stem cell transplant (ASCT).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR) (per International Myeloma Working Group \[IMWG\] criteria) of FDVd.
II. Determine the time to response (TTR). III. Determine the duration of response (DOR). IV. Determine the progression-free survival (PFS) at 1 year. V. Determine the overall survival (OS) at 1 year.
CORRELATIVE OBJECTIVES:
I. Baseline and end of-study plasma cell expression of CD38. II. Changes in lymphocyte subsets with therapy. III. Baseline and end-of study analysis of total number and ratio of regulatory T cells (Tregs) with CD38+ expression.
IV. Check minimal residual disease (MRD) negativity rates by next generation sequencing in patients who attain and maintain very good partial response (VGPR) or better for at least three months.
OUTLINE: This is a dose-escalation study of panobinostat.
Patients receive panobinostat orally (PO) once daily (QD) on days 1, 3, 5, 15, 17, 19, daratumumab and hyaluronidase-fihj subcutaneously (SC) on days 1, 8, 15, 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, bortezomib SC on days 1, 8, 15, 22 and dexamethasone PO (intravenously \[IV\] on days of daratumumab and hyaluronidase-fihj administration) QD on days 1, 8, 15, 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up on days 30 and 60.
I. To evaluate the safety and tolerability of Farydak (panobinostat lactate)/Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Velcade (bortezomib)/dexamethasone (FDVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have previously received one line of therapy including lenalidomide or cyclophosphamide, bortezomib (V) or other proteasome inhibitor (PI), with or without autologous stem cell transplant (ASCT).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR) (per International Myeloma Working Group \[IMWG\] criteria) of FDVd.
II. Determine the time to response (TTR). III. Determine the duration of response (DOR). IV. Determine the progression-free survival (PFS) at 1 year. V. Determine the overall survival (OS) at 1 year.
CORRELATIVE OBJECTIVES:
I. Baseline and end of-study plasma cell expression of CD38. II. Changes in lymphocyte subsets with therapy. III. Baseline and end-of study analysis of total number and ratio of regulatory T cells (Tregs) with CD38+ expression.
IV. Check minimal residual disease (MRD) negativity rates by next generation sequencing in patients who attain and maintain very good partial response (VGPR) or better for at least three months.
OUTLINE: This is a dose-escalation study of panobinostat.
Patients receive panobinostat orally (PO) once daily (QD) on days 1, 3, 5, 15, 17, 19, daratumumab and hyaluronidase-fihj subcutaneously (SC) on days 1, 8, 15, 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, bortezomib SC on days 1, 8, 15, 22 and dexamethasone PO (intravenously \[IV\] on days of daratumumab and hyaluronidase-fihj administration) QD on days 1, 8, 15, 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up on days 30 and 60.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-04261 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |