Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM (NCT04653246) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
United States52 participantsStarted 2021-07-13
Plain-language summary
This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.
Who can participate
Age range75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
* Provided voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
* Age ≤ 75 years, with patients over the age of 70 requiring PI approval
* Measurable disease defined as at least one of the following:
* Serum M protein ≥ 0.5 g/dL (≥5 g/L)
* Urine M protein ≥ 200 mg/24 hours
* Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
* Screening Laboratory evaluations within the following parameters
* Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used within 14 days before first drug administration)
* Platelet count ≥ 75,000 cells/dL (75 x 109/L) if \< 50% BM nucleated cells are plasma cells, ≥ 30,000 cells/dL if ≥ 50% of BM nucleated cells are plasma cells. (without transfusions required during the 3 days prior to the screening hematologic test)
* Total Bilirubin ≤ 2.0 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
* Calculated creatinine clearance ≥ 30 mL/min
* Hemoglobin ≤ 8 g/dL
* ECOG performance status ≤ 2 (Appendix A)
* Participant…