NCT03155100

Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines

Phase 2 Study of Carfilzomib + Elotuzumab + Dexamethasone for Relapsed or Progressed Multiple Myeloma After 1-3 Prior Treatment Lines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Raija Silvennoinen · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).

Detailed description

This Nordic Myeloma Study Group study is a phase 2 study for advanced multiple myeloma (MM) patients below 75 years of age. The main aim of this study is to assess the overall response rate (ORR) with a new drug combination, carfilzomib + elotuzumab + dexamethasone (CAR-ELO-Dex). Even if this is not a randomized study rough comparisons can be done with earlier reports of different regimens in the same clinical situation. In addition, safety assessment is of critical importance for a new regimen. A modern concept is to study the depth of complete responses (CR) with a sensitive multiparameter flow cytometry (MFC) method for minimal residual disease (MRD) assessment - an endpoint that is mostly lacking in previous studies for this patient population. We assume that treatment with this new combination of CAR + ELO + Dex will produce at least as good responses as the most efficient regimens so far used in this clinical situation, and there will be a substantial proportion of CR responses with MRD-negativity which can be regarded as an indicator of high-level treatment efficacy and which gives a good basis for comparisons of treatment efficacy between different study regimens in future. The target population of the study is the patients who have relapsed or progressed after 1 to 3 prior treatment lines in which PI (bortezomib and/or ixazomib) and/or lenalidomide have been included. The primary endpoint is overall response rate while the secondary endpoints include complete remission, duration of response, assessment of the depth (quality) of CR with MRD measurement by flow cytometry, estimation of progression free survival (PFS) and time to next treatment, and evaluation of adverse events and safety.

Conditions

• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
DRUG	Carfilzomib for Inj 60 milligram (MG)	All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
DRUG	Elotuzumab 400 MG	All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
DRUG	Dexamethasone	All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone

Timeline

• Start date: 2017-08-07
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2017-05-16
• Last updated: 2023-09-26

Locations

8 sites across 2 countries: Finland, Sweden