Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple … (NCT05392946) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
United States49 participantsStarted 2022-08-11
Plain-language summary
This phase I/II trial studies the side effects and best dose of iberdomide and how well it works in combination with daratumumab, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as dexamethasone, 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. Giving iberdomide in combination with daratumumab, bortezomib, and dexamethasone may kill more cancer cells in patients with newly diagnosed multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age \>= 18 years at the time of signing the informed consent form (ICF)
* Previously untreated active/symptomatic multiple myeloma or have received no more than one cycle of any anti-myeloma treatment regimen for active/symptomatic myeloma
* NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted. Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted. Any additional agents not listed must be approved by the principal investigator
* Measurable disease
* Serum M-protein ≥0.5 g/dL
* Urine M-protein ≥200 mg in a 24-hour collection
* Serum Free Light Chain level ≥ 10 mg/dL provided the free light chain ratio is abnormal
* Measurable plasmacytoma \[at least one lesion that has a single diameter of ≥2 cm on positron emission tomography (PET)-computed tomography (CT) scan\]
* Bone marrow plasma cells≥30%
* Patients with IgA myeloma in whom serum protein electrophoresis is deemed unreliable, due to co-migration of normal serum proteins with the para protein in the beta region, may be considered eligible as long as total serum IgA level is elevated above normal range.
* For patients with extramedullary disease (EMD) measurable by CT or MRI or the CT portion of the PET/CT: Must have at least one lesion that has a single diameter of ≥2 cm. Skin lesions can be used if the area is ≥2cm in at least one diameter and measured with a ruler.
* Eastern Cooperat…
What they're measuring
1
Maximum tolerated dose (MTD) of iberdomide (Phase I)
Timeframe: Up to 12 cycles. Each cycle is 28 days.