Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566328
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-09-16
Brief Title:
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma the EQUATE Trial
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Effective Quadruplet Utilization After Treatment Evaluation EQUATE A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This phase III trial compares the combination of four drugs daratumumab bortezomib lenalidomide and dexamethasone to the use of a three drug combination daratumumab lenalidomide and dexamethasone Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Chemotherapy drugs such as lenalidomide work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread Anti-inflammatory drugs such as dexamethasone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer Adding bortezomib to daratumumab lenalidomide and dexamethasone may be more effective in shrinking the cancer or preventing it from returning compared to continuing on daratumumab lenalidomide and dexamethasone
Detailed Description:
PRIMARY OBJECTIVE
I To determine if bortezomib daratumumab and hyaluronidase-fihj daratumumab lenalidomide and dexamethasone Btz-DRd consolidation followed by daratumumab and lenalidomide DR maintenance after standard induction therapy with daratumumab lenalidomide and dexamethasone DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in minimal residual disease MRD positive patients
SECONDARY OBJECTIVES
I To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in MRD negative patients
II To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior progression-free survival compared to DRd consolidation followed by DR maintenance in both MRD positive and MRD negative patients
III To describe and compare the incidence of toxicities during consolidation between Btz-DRd and DRd arms
IV To assess the improvement in MRD negative rate with consolidation among patients who are MRD positive after induction
V To assess the sustained MRD negative rate among patients who are MRD negative after induction
PATIENT REPORTED OUTCOMES PRO OBJECTIVES
I To quantify the extent to which the addition of bortezomib to DRd over consolidation treatment contributes to neuropathy and associated physical and functional impairments Primary PRO Objective II To evaluate the rate of resolution of neurotoxicity and associated physical and functional impairments following completion of consolidation therapy Secondary PRO Objective III To investigate the relationship between MRD status and patient reported health-related quality of life outcomes Exploratory PRO Objective IV To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events PRO- Common Terminology Criteria for Adverse Events CTCAE longitudinally and compare responses with provider-reported adverse events Exploratory PRO Objective V To tabulate PRO compliance and completion rates Exploratory PRO Objective
IMAGING OBJECTIVES
I To evaluate the association between post-induction fludeoxyglucose F-18 18F-FDG positron emission tomography PETcomputed tomography CT and patient outcomes overall survival OS and progression-free survival PFS Primary Imaging Objective II To evaluate the association between baseline 18F-FDG PETCT and patient outcomes PFS and OS Secondary Imaging Objective III To compare overall survival with the addition of Bortezomib to consolidation DRd therapy among 18F-FDG PETCT-positive and 18F-FDG PETCT-negative subgroups Secondary Imaging Objective IV To evaluate the ability of baseline 18F-FDG PETCT to predict post-induction depth of response as measured by MRD assessment Secondary Imaging Objective V To evaluate the ability of post-induction 18F-FDG PETCT to predict MRD conversion post-consolidation Secondary Imaging Objective VI To utilize 18F-FDG PETCT standard risk factors and clinical data to identify distinct subgroups with differing patient outcomes PFS and OS Exploratory Imaging Objective VII To compare the various qualitative 18F-FDG PETCT criteria to determine which criteria yields superior risk stratification Exploratory Imaging Objective
OUTLINE
ARM A INDUCTION All patients receive standard induction therapy comprising the following daratumumab subcutaneously SC on days 1 8 15 and 22 of cycles 1-2 days 1 and 15 of cycles 3-6 and day 1 of cycles 7-9 lenalidomide orally PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
After completion of standard induction therapy patients are randomized to 1 of 2 arms
ARM B
CONSOLIDATION Patients receive bortezomib SC on days 1 8 and 15 daratumumab SC on day 1 lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM C
CONSOLIDATION Patients receive daratumumab SC on day 1 lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1 Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months if less than 2 years from study entry every 6 months if 2-5 years from study entry then annually for up to 15 years from study entry
I To determine if bortezomib daratumumab and hyaluronidase-fihj daratumumab lenalidomide and dexamethasone Btz-DRd consolidation followed by daratumumab and lenalidomide DR maintenance after standard induction therapy with daratumumab lenalidomide and dexamethasone DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in minimal residual disease MRD positive patients
SECONDARY OBJECTIVES
I To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in MRD negative patients
II To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior progression-free survival compared to DRd consolidation followed by DR maintenance in both MRD positive and MRD negative patients
III To describe and compare the incidence of toxicities during consolidation between Btz-DRd and DRd arms
IV To assess the improvement in MRD negative rate with consolidation among patients who are MRD positive after induction
V To assess the sustained MRD negative rate among patients who are MRD negative after induction
PATIENT REPORTED OUTCOMES PRO OBJECTIVES
I To quantify the extent to which the addition of bortezomib to DRd over consolidation treatment contributes to neuropathy and associated physical and functional impairments Primary PRO Objective II To evaluate the rate of resolution of neurotoxicity and associated physical and functional impairments following completion of consolidation therapy Secondary PRO Objective III To investigate the relationship between MRD status and patient reported health-related quality of life outcomes Exploratory PRO Objective IV To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events PRO- Common Terminology Criteria for Adverse Events CTCAE longitudinally and compare responses with provider-reported adverse events Exploratory PRO Objective V To tabulate PRO compliance and completion rates Exploratory PRO Objective
IMAGING OBJECTIVES
I To evaluate the association between post-induction fludeoxyglucose F-18 18F-FDG positron emission tomography PETcomputed tomography CT and patient outcomes overall survival OS and progression-free survival PFS Primary Imaging Objective II To evaluate the association between baseline 18F-FDG PETCT and patient outcomes PFS and OS Secondary Imaging Objective III To compare overall survival with the addition of Bortezomib to consolidation DRd therapy among 18F-FDG PETCT-positive and 18F-FDG PETCT-negative subgroups Secondary Imaging Objective IV To evaluate the ability of baseline 18F-FDG PETCT to predict post-induction depth of response as measured by MRD assessment Secondary Imaging Objective V To evaluate the ability of post-induction 18F-FDG PETCT to predict MRD conversion post-consolidation Secondary Imaging Objective VI To utilize 18F-FDG PETCT standard risk factors and clinical data to identify distinct subgroups with differing patient outcomes PFS and OS Exploratory Imaging Objective VII To compare the various qualitative 18F-FDG PETCT criteria to determine which criteria yields superior risk stratification Exploratory Imaging Objective
OUTLINE
ARM A INDUCTION All patients receive standard induction therapy comprising the following daratumumab subcutaneously SC on days 1 8 15 and 22 of cycles 1-2 days 1 and 15 of cycles 3-6 and day 1 of cycles 7-9 lenalidomide orally PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
After completion of standard induction therapy patients are randomized to 1 of 2 arms
ARM B
CONSOLIDATION Patients receive bortezomib SC on days 1 8 and 15 daratumumab SC on day 1 lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM C
CONSOLIDATION Patients receive daratumumab SC on day 1 lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1 Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months if less than 2 years from study entry every 6 months if 2-5 years from study entry then annually for up to 15 years from study entry
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |
| NCI-2020-06647 | REGISTRY | None | None |
| EAA181 | OTHER | None | None |
| EAA181 | OTHER | None | None |