Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT ID: NCT04883242
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2021-07-29
2031-12-31
Brief Summary
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Detailed Description
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INDUCTION: Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) once daily (QD) on days 1-21, and dexamethasone PO or IV on days 1,8, 15, and 22. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive isatuximab IV days 1 and 15, carfilzomib IV over 30 minutes on days 1 and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
All patients undergo bone marrow aspirate and biopsy during screening, skeletal x-ray, computed tomography (CT), positron emission tomography (PET)-CT, or magnetic resonance imaging (MRI), bone marrow and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, then for up to 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (isatuximab, carfilzomib, pomalidomide, steroid)
INDUCTION: Patients receive isatuximab IV on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1,8, 15, and 22. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive isatuximab IV days 1 and 15, carfilzomib IV over 30 minutes on days 1 and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
All patients undergo bone marrow aspirate and biopsy during screening, skeletal x-ray, CT, PET-CT, or MRI, bone marrow and blood sample collection throughout the study.
Carfilzomib
Given IV
Dexamethasone
Given PO or IV
Isatuximab
Given IV
Pomalidomide
Given PO
Bone Marrow Biopsy
Undergo bone marrow biopsy
Bone Marrow Aspiration
Undergo bone marrow aspiration
Skeletal Survey X-Ray
Undergo skeletal x-ray
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET-CT
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Carfilzomib
Given IV
Dexamethasone
Given PO or IV
Isatuximab
Given IV
Pomalidomide
Given PO
Bone Marrow Biopsy
Undergo bone marrow biopsy
Bone Marrow Aspiration
Undergo bone marrow aspiration
Skeletal Survey X-Ray
Undergo skeletal x-ray
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET-CT
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have received prior lenalidomide therapy
* Must have measurable disease, as defined by International Myeloma Working Group criteria, having one or more of the following:
* Serum M protein \>= 0.5 g/dL
* Urine M protein \>= 200 mg/24 hours
* Involved serum free light chain level \>= 10 mg/dL with abnormal kappa/lambda ratio
* Measurable biopsy-proven plasmacytomas (\>= 1 lesion has a single diameter \>= 2 cm)
* Bone marrow plasma cells \>= 30%
* Age 18 years and older, and have the capacity to give informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Subjects should have resolution of any toxicities from prior therapy to grade =\< 1 or baseline prior to enrollment (with the exception of peripheral neuropathy)
* Subjects are required to have grade =\< 2 peripheral neuropathy to enroll
* Prior autologous stem cell transplant is allowed; patients must be \>= 6 months post- autologous stem cell transplantation to enroll
* Estimated glomerular filtration rate (eGFR) \>= 20 ml/min
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN)
* Total bilirubin =\< 2 x ULN
* Absolute neutrophil count (ANC) \>= 1,000/uL
* Platelets \>= 50,000/uL
* Hemoglobin \>= 8 g/dL
* Growth factor use or transfusions may be used to meet the eligibility requirement for ANC, platelets, and hemoglobin
* Female patients of childbearing potential and male patients must agree to use 2 effective forms of contraception or continuously abstain from heterosexual intercourse during the period of therapy, and for 6 months after discontinuation of study treatment for females and 3 months after discontinuation of study treatment for males
Exclusion Criteria
* Uncontrolled hypertension as determined by the principal investigator (PI) or designee
* Active plasma cell leukemia or systemic amyloid light-chain (AL) amyloidosis
* History of another primary malignancy that has not been in remission for at least 1 year
* However, the following diagnoses are eligible for inclusion: non-melanoma skin cancer, localized prostate cancer, superficial bladder cancer, cervical carcinoma in situ, on biopsy or any prior malignancy with an estimated \> 90% 1-year cure rate per sponsor-investigator
* For patients with chronic hepatitis B viral infection, the hepatitis B virus (HBV) polymerase chain reaction (PCR) must be undetectable on suppressive therapy
* Patients with a history of Hepatitis C viral infection must have been treated and cured. For patients on treatment for hepatitis C, they are eligible if they have an undetectable hepatitis C virus (HCV) viral load
* Subjects with active uncontrolled infection
* Concurrent use of other anticancer agents or experimental treatments
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Rahul Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-03406
Identifier Type: REGISTRY
Identifier Source: secondary_id
10690
Identifier Type: OTHER
Identifier Source: secondary_id
RG1121154
Identifier Type: -
Identifier Source: org_study_id
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