Title
Carfilzomib and lenalidomide-based treatment for transplant eligible and non-transplant eligible newly diagnosed primary plasma cell leukemia patientsStudy map
Overview / Summary
Study objectives:
- To evaluate progression-free survival in adult pPCL patients by incorporation of carfilzomib and lenalidomide in induction, consolidation, and maintenance therapy.
- To assess overall response rate and (s)CR + VGPR ((stringent) complete and very good partial response) rate after induction therapy, after HDM, after CRd consolidation, after RIC allo-SCT or a second HDM, and during maintenance.
- To evaluate overall survival.
- To assess safety and toxicity.
- To assess the prognostic value of risk factors at diagnosis, including β2-microglobulin, LDH, FISH abnormalities del1p, ampli 1q, t(4;14), t(14;16), t(11;14), ampli 9, del13q/13-, del17p as analyzed in purified bone marrow plasma cells with respect to progression-free survival.
- To analyze the prognostic value of myeloma gene expression profiles.
- To analyze the prognostic value of minimal-residual disease negativity.
- To assess the prognostic value of mutations as determined by sequencing.
- To establish the frequency of second primary malignancies (SPM).
Study details
Patient eligibility criteria
Inclusion criteria
- Patients with diagnosis of symptomatic pPCL (see appendix A)
- Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 10 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
Exclusion criteria
- Any current CNS involvement with disease refractory to intrathecal chemotherapy.
