NCT03746652

Safety and Efficacy of Daratumumab in Combination With Ixazomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2, Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Ixazomib and Dexamethasone as Second Line Therapy in Multiple Myeloma Patients Who Have Received Prior Treatment With a Lenalidomide Based Regimen

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hellenic Society of Hematology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of daratumumab in combination with ixazomib and dexamethasone as second line treatment for relapsed Multiple Myeloma patients.

Detailed description

This is a Phase 2, single-arm study of daratumumab in combination with ixazomib and dexamethasone as second line treatment for relapsed Multiple Myeloma patients initially treated with lenalidomide-based regimens. Daratumumab is a human IgG1ĸ monoclonal antibody that binds with high affinity to a unique epitope on CD38, a transmembrane glycoprotein. It is a targeted immunotherapy that attacks tumor cells that overexpress CD38, in a variety of hematological malignancies including multiple myeloma. Ixazomib is an orally administered proteasome inhibitor with anti-myeloma activity.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab, Ixazomib, Dexamethasone	Daratumumab 16 mg/kg, Ixazomib 4 mg, Dexamethasone 40 mg

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-11-20
• Last updated: 2018-11-23

Locations

1 site across 1 country: Greece