Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232044
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-01-22
Brief Title:
Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Study of the Safety Tolerability and Efficacy of Belantamab Mafodotin GSK2857916 in Combination With Iberdomide CC-220Dexamethasone Versus Belantamab Mafodotin GSK2857916Dexamethasone in Relapsed Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 tests the safety side effects best dose and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma MM that has come back after a period of improvement relapsed or that does not respond to treatment refractory Multiple myeloma is a cancer that affects white blood cells called plasma cells which are made in the bone marrow and are part of the immune system Multiple myeloma cells have a protein on their surface called B-cell maturation antigen BCMA that allows the cancer cells to survive and grow Immunotherapy with iberdomide may induce changes in bodys immune system and may interfere with the ability of cancer cells to grow and spread Belantamab mafodotin has been designed to attach to the BCMA protein which may cause the myeloma cell to become damaged and die Dexamethasone is in a class of medications called corticosteroids It is used to reduce inflammation and lower the bodys immune response to help lessen the side effects of chemotherapy drugs Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I To determine maximum tolerated dose MTD of iberdomide CC-220 in combination with belantamab mafodotin and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM PHASE I II To determine whether the combination of belantamab mafodotin iberdomidedexamethasone improves progression-free survival PFS relative to belantamab mafodotindexamethasone in patients with RRMM PHASE II
SECONDARY OBJECTIVES
I To summarize the incidence and cause for treatment delays modifications and omissions PHASE I II To assess treatment response PHASE I III To obtain an estimate of the progression-free survival PFS and overall survival OS distribution PHASE I IV To determine minimal residual disease MRD negativity PHASE I V To observe and record anti-tumor activity PHASE I VI To determine whether the combination of belantamab mafodotin iberdomidedexamethasone improves overall survival OS compared to belantamab mafadotindexamethasone in patients with RRMM PHASE II VII To evaluate the safety profile PHASE II VIII To estimate the ORR per International Myeloma Working Group IMWG criteria duration of response DoR and time to relapse TTR PHASE II XI To determine MRD status PHASE II
EXPLORATORY OBJECTIVES
I To examine changes in T NK and B-cell subsets and quantitative immunoglobulin levels after 1 3 6 and 12 cycles of treatment
II To investigate whether BCMA protein expression on MM cells at diagnosis as well as at relapse or end of study including loss of expression is associated with outcome OS and PFS
OUTLINE This is a phase I dose-escalation study of iberdomide followed by a phase II study
PHASE I Patients receive iberdomide orally on days 1-21 and 29-49 belantamab mafodotin intravenously IV on day 1 and dexamethasone orally PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography ECHO during screening as clinically indicated and computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PET scans during screening and as clinically indicated on study Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial
PHASE II Patients are randomized to 1 of 2 arms
ARM I Patients receive belantamab mafodotin IV on day 1 and dexamethasone PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients who progress may cross over to Arm II Patients undergo ECHO during screening as clinically indicated and CT MRI andor PET scans during screening and as clinically indicated on study Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial
ARM II Patients receive iberdomide orally on days 1-21 and 29-49 belantamab mafodotin IV on day 1 and dexamethasone PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients undergo ECHO during screening as clinically indicated and CT MRI andor PET scans during screening and as clinically indicated on study Patients also undergo bone marrow biopsy and aspiration and blood sample collection throughout trial
After completion of study treatment patients are followed up every 6 months for 3 years from study entry
I To determine maximum tolerated dose MTD of iberdomide CC-220 in combination with belantamab mafodotin and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM PHASE I II To determine whether the combination of belantamab mafodotin iberdomidedexamethasone improves progression-free survival PFS relative to belantamab mafodotindexamethasone in patients with RRMM PHASE II
SECONDARY OBJECTIVES
I To summarize the incidence and cause for treatment delays modifications and omissions PHASE I II To assess treatment response PHASE I III To obtain an estimate of the progression-free survival PFS and overall survival OS distribution PHASE I IV To determine minimal residual disease MRD negativity PHASE I V To observe and record anti-tumor activity PHASE I VI To determine whether the combination of belantamab mafodotin iberdomidedexamethasone improves overall survival OS compared to belantamab mafadotindexamethasone in patients with RRMM PHASE II VII To evaluate the safety profile PHASE II VIII To estimate the ORR per International Myeloma Working Group IMWG criteria duration of response DoR and time to relapse TTR PHASE II XI To determine MRD status PHASE II
EXPLORATORY OBJECTIVES
I To examine changes in T NK and B-cell subsets and quantitative immunoglobulin levels after 1 3 6 and 12 cycles of treatment
II To investigate whether BCMA protein expression on MM cells at diagnosis as well as at relapse or end of study including loss of expression is associated with outcome OS and PFS
OUTLINE This is a phase I dose-escalation study of iberdomide followed by a phase II study
PHASE I Patients receive iberdomide orally on days 1-21 and 29-49 belantamab mafodotin intravenously IV on day 1 and dexamethasone orally PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography ECHO during screening as clinically indicated and computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PET scans during screening and as clinically indicated on study Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial
PHASE II Patients are randomized to 1 of 2 arms
ARM I Patients receive belantamab mafodotin IV on day 1 and dexamethasone PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients who progress may cross over to Arm II Patients undergo ECHO during screening as clinically indicated and CT MRI andor PET scans during screening and as clinically indicated on study Patients also undergo a bone marrow biopsy and aspiration and blood sample collection throughout trial
ARM II Patients receive iberdomide orally on days 1-21 and 29-49 belantamab mafodotin IV on day 1 and dexamethasone PO on days 1 8 15 22 29 36 43 and 50 of each cycle Cycles repeat every 56 days in the absence of disease progression or unacceptable toxicity Patients undergo ECHO during screening as clinically indicated and CT MRI andor PET scans during screening and as clinically indicated on study Patients also undergo bone marrow biopsy and aspiration and blood sample collection throughout trial
After completion of study treatment patients are followed up every 6 months for 3 years from study entry
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