Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06948084
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This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.
Interventions
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Biospecimen Collection
(Procedure)
Undergo urine and blood sample collection
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Bone Marrow Biopsy
(Procedure)
Undergo bone marrow biopsy
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Carfilzomib
(Drug)
Given IV
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Computed Tomography
(Procedure)
Undergo FDG PET/CT
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Daratumumab and Recombinant Human Hyaluronidase
(Drug)
Given SC
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Dexamethasone
(Drug)
Given PO or IV
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FDG-Positron Emission Tomography
(Procedure)
Undergo FDG PET/CT
-
Pomalidomide
(Drug)
Given PO
-
Teclistamab
(Drug)
Given SC
Eligibility criteria
Conditions
Locations
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
- Illinois CancerCare-Pekin — Pekin, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- Illinois CancerCare-Peru — Peru, Illinois, United States
- Illinois CancerCare-Princeton — Princeton, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Illinois CancerCare - Washington — Washington, Illinois, United States
- Mercy Hospital — Cedar Rapids, Iowa, United States
- Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
- LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States
- Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
- Billings Clinic Cancer Center — Billings, Montana, United States
- Benefis Sletten Cancer Institute — Great Falls, Montana, United States
- Logan Health Medical Center — Kalispell, Montana, United States
- Community Medical Center — Missoula, Montana, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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