Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790474
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2021-03-07
Brief Title:
Ixazomib-pomalidomide-dexamethasone As Second or Third-line Combination Treatment for Patients with Relapsed and Refractory Multiple Myeloma Previously Treated with Daratumumab Lenalidomide and Bortezomib
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
A Single-arm Multisite Prospective Study of Ixazomib-pomalidomide-dexamethasone As Second or Third-line Combination Treatment for Patients with Relapsed and Refractory Multiple Myeloma RRMM Previously Treated with Daratumumab Lenalidomide and Bortezomib IPoD-790 Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
IPoD-790
Brief Summary:
Adult patients with a confirmed diagnosis of symptomatic and relapsed andor refractory MM after receiving bortezomib lenalidomide and daratumumab during first and second lines will be eligible to be enrolled in this study
During the first three treatment cycles patients will be seen twice Days 1 and 15 of the cycle Starting from cycle 4 and on patients will be assessed once per cycle Day 1 until disease progression for disease response and progression according to the International Myeloma Working Group IMWG criteria After progression all patients will be followed for survival for this purpose patients will be contacted every 12 weeks until death or termination of the study by the Sponsor
Patients may continue to receive treatment for 24 months or until disease progression PD or unacceptable toxicity the earlier of the three Dose modifications may be made based on toxicities Patients who complete study therapy will continue to receive treatment per standard of care
During the first three treatment cycles patients will be seen twice Days 1 and 15 of the cycle Starting from cycle 4 and on patients will be assessed once per cycle Day 1 until disease progression for disease response and progression according to the International Myeloma Working Group IMWG criteria After progression all patients will be followed for survival for this purpose patients will be contacted every 12 weeks until death or termination of the study by the Sponsor
Patients may continue to receive treatment for 24 months or until disease progression PD or unacceptable toxicity the earlier of the three Dose modifications may be made based on toxicities Patients who complete study therapy will continue to receive treatment per standard of care
Detailed Description:
This phase 2 open-label single-arm prospective multicenter study will evaluate the safety tolerability and efficacy of ixazomib-pomalidomide-dexamethasone IPD as a second or third-line combination treatment for patients with relapsed andor refractory multiple myeloma RRMM who progressed after receiving bortezomib lenalidomide and daratumumab during first and second lines The patient population will consist of adult men and women who have a confirmed diagnosis of MM who have received two prior lines of therapy and who meet other outlined eligibility criteria Following confirmation of eligibility enrolled patients will be treated with pomalidomide plus dexamethasone as standard of care and will also receive ixazomib as a study drug
The treatment regimen will involve administration of the following drugs
Cycles 1-3 during each 21-day cycle
ixazomib 3 mg on Days 1 4 8 and 11
pomalidomide 4 mg on Days 1 through 14
dexamethasone 20 mg on Days 1 2 8 9 15 16
Cycle 4 and consequently during each 28-day cycle
ixazomib 4 mg on Days 1 8 and 15
pomalidomide 4 mg on Days 1 through 21
dexamethasone 20 mg on Days 1 2 8 9 15 16 22 and 23 Patients may continue to receive treatment for 24 months or until disease progression PD or unacceptable toxicity the earlier of the three Dose modifications may be made based on toxicities Patients who complete study therapy will continue to receive treatment per standard of care
The main efficacy outcome- Progression Free Survival PFS is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause PFS will be determined by an investigator based upon laboratory data as defined by the IMWG criteria
Secondary EndpointsObjective response rate ORRis defined as the proportion of patients who achieve a best overall response of stringent complete response sCR complete response CR very good partial response VGPR or partial response PR as defined using the IMWG criteria
Overall Survival OS OS is defined as the time between the date of first dose and the date of death due to any cause OS will be censored on the last date a subject was known to be alive
Time to Response TTR Time to Response is defined as the time from the first dose to the date of the first sCR CR VGPR or PR TTR will be evaluated for responders Duration of Response DOR Duration of Response is defined as the time between the date of first response to the date of the first objectively documented tumor progression as assessed by study steering committee according to modified IMWG criteria or death due to any cause prior to subsequent anti-cancer therapy
Optional Exploratory Analysis RNA sequencing by Massive Parallel MARS-seq method of fresh or frozen cluster of differentiation 38 CD38CD138 plasma cells normal and malignant in the bone marrow of patients
The treatment regimen will involve administration of the following drugs
Cycles 1-3 during each 21-day cycle
ixazomib 3 mg on Days 1 4 8 and 11
pomalidomide 4 mg on Days 1 through 14
dexamethasone 20 mg on Days 1 2 8 9 15 16
Cycle 4 and consequently during each 28-day cycle
ixazomib 4 mg on Days 1 8 and 15
pomalidomide 4 mg on Days 1 through 21
dexamethasone 20 mg on Days 1 2 8 9 15 16 22 and 23 Patients may continue to receive treatment for 24 months or until disease progression PD or unacceptable toxicity the earlier of the three Dose modifications may be made based on toxicities Patients who complete study therapy will continue to receive treatment per standard of care
The main efficacy outcome- Progression Free Survival PFS is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause PFS will be determined by an investigator based upon laboratory data as defined by the IMWG criteria
Secondary EndpointsObjective response rate ORRis defined as the proportion of patients who achieve a best overall response of stringent complete response sCR complete response CR very good partial response VGPR or partial response PR as defined using the IMWG criteria
Overall Survival OS OS is defined as the time between the date of first dose and the date of death due to any cause OS will be censored on the last date a subject was known to be alive
Time to Response TTR Time to Response is defined as the time from the first dose to the date of the first sCR CR VGPR or PR TTR will be evaluated for responders Duration of Response DOR Duration of Response is defined as the time between the date of first response to the date of the first objectively documented tumor progression as assessed by study steering committee according to modified IMWG criteria or death due to any cause prior to subsequent anti-cancer therapy
Optional Exploratory Analysis RNA sequencing by Massive Parallel MARS-seq method of fresh or frozen cluster of differentiation 38 CD38CD138 plasma cells normal and malignant in the bone marrow of patients
Study Oversight
Has Oversight DMC:
None
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?:
None