CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma.

Summary

Participation Requirements

Description

Primary Objective 1. To determine the MTD and RP2D for pomalidomide that can safely be administered with DARA and cyclophosphamide. Primary Endpoint 1. To determine the incidence of DLT within the first cycle of CPD in combination with DARA at each dose level. Secondary Objectives To evaluate the sa...

Primary Objective 1. To determine the MTD and RP2D for pomalidomide that can safely be administered with DARA and cyclophosphamide. Primary Endpoint 1. To determine the incidence of DLT within the first cycle of CPD in combination with DARA at each dose level. Secondary Objectives To evaluate the safety and tolerability of the CPD-DARA regimen. To evaluate efficacy measures. Secondary Endpoints 1. Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). Adverse events grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0. 2. The following efficacy endpoints will be measured: i. Complete Response (CR) rate after six cycles of CPD-DARA and at the end of study treatment. ii. Best Overall Response. iii. Minimal Residual Disease (MRD) negative rate after six cycles of CPD-DARA. iv. Progression Free Survival (PFS) and Overall Survival (OS) at 6 months and 2 years. v. Time to Response. Exploratory Objectives To assess effect of CPD-DARA treatment on patient-reported outcomes and quality of life. Efficacy according to the IMWG (International Myeloma Working Group) in High Risk vs Standard Risk patients. Disease Control Rate (DCR). Exploratory Endpoints 1. To assess effect of CPD-DARA treatment on patient-reported outcomes and quality of life, as assessed by the FACT-G and MyPOS questionnaires completed at study commencement, at every cycle of study treatment and at completion of the study treatment. 2. Efficacy according to the IMWG in High Risk (defined by ISS stage 3 and/or high-risk cytogenetic findings including t(4;14), t(14;16), and del17p) vs Standard Risk patients. 3. Disease Control Rate (DCR) defined as stable disease or better.

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