Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untrea… (NCT01029054) | Clinical Trial Compass
CompletedPhase 1/2
Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma
United States53 participantsStarted 2009-09
Plain-language summary
This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myeloma patients who have not received treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed, histologically confirmed, previously untreated Stage I, II, or III multiple myeloma requiring systemic chemotherapy
✓. Diagnosis of symptomatic multiple myeloma per IMWG uniform criteria within the past 90 days
✓. Measurable disease, per IMWG (International Myeloma Working Group) criteria (\>= one of the following) within the past 4 weeks:
✓. Life expectancy \> 3 months
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Adequate hepatic function, with bilirubin \< 1.5 x the ULN, and AST (Aspartate Aminotransferase) and ALT (Alanine Transaminase) \< 2.5 x ULN
✓. Absolute neutrophil count (ANC) \>=1.0 x 109/L, hemoglobin \>= 8 g/dL, platelet count \>= 75 x 109/L
✕. Non-secretory or hyposecretory multiple myeloma, defined as \<0.5 g/dL M-protein in serum, \<200 mg/24 hr urine M-protein, or disease only measured by serum free light chain
✕. Radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
✕. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
✕. Participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater