Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet (NCT04191616) | Clinical Trial Compass
CompletedPhase 2
Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
United States54 participantsStarted 2020-08-06
Plain-language summary
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria
* Subject has provided informed consent prior to initiation of any study specific activities or procedures.
* Male or female subjects age ≥ 18 years
* First or second relapse of multiple myeloma by IMWG criteria (subjects refractory to the most recent line of therapy, excluding carfilzomib, are eligible)
* Refractory to lenalidamide
* Measurable disease with at least 1 of the following assessed within 28 days prior to enrollment:
* IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
* IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL
* urine M-protein ≥ 200 mg per 24 hours
* in subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
* Must have at least a PR to at least 1 line of prior therapy
* Prior therapy with proteasome inhibitors is allowed. Subjects receiving prior carfilzomib therapy must have achieved at least a PR, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval from their last dose of carfilzomib
* ECOG PS of 0 to 2
Exclusion Criteria
* Primary refractory multiple myeloma
* Waldenström macroglobulinemia
* Multiple myeloma of IgM subtype
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Plasma cell leukemia ( greater than 2…
What they're measuring
1
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
Timeframe: From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks