Ixazomib + Pomalidomide + Dexamethasone In MM (NCT04094961) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Ixazomib + Pomalidomide + Dexamethasone In MM
United States52 participantsStarted 2019-09-18
Plain-language summary
This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with relapsed and relapsed refractory myeloma may be eligible for this trial of they meet all the following entry criteria.
* Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment.
* Patient has given 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performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
* Patient had received at least two previous therapies OR received 1 prior line of therapy if previously treated with an IMiD plus a proteasome inhibitor and has demonstrated disease progression on or within 60 days of completion of the last therapy
* Patient has measurable disease defined as at least one of the following according to Standard Diagnostic Criteria (Rajkumar 2014):
* Serum IgG, IgA, or IgM M-protein ≥ 0.5 g/dL, or
* Serum IgD M-protein ≥ 0.05 g/dL, or
* Urine M protein ≥200 mg/24 hours or
* 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 more recently than 14 days prior to initiation of therapy)
* Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions required during the 14 days pr…
What they're measuring
1
Number of participants with dose limiting toxicity