NCT02186834

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

Investigator-Initiated Phase I/II Clinical Trial of Selinexor (KPT-330) and Liposomal Doxorubicin for Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the recommended doses of selinexor in combination with liposomal doxorubicin and dexamethasone for patients with relapsed and refractory myeloma. In addition, the study will assess whether this combination with effective for patients with multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor orally as outlined in the study treatment arm.
DRUG	Liposomal doxorubicin	Pegylated liposomal doxorubicin at a starting dose of 20 mb/m² as outlined in the treatment arm.
DRUG	Dexamethasone	Participants will be instructed to take Dexamethasone 40 mg (10 tablets) orally once weekly with meals (ideally with breakfast to minimize insomnia). Participants older than 75 years and patients previously intolerant to 40 mg dosage will be allowed to receive 20 mg (5 tablets) once a week.

Timeline

• Start date: 2014-09-23
• Primary completion: 2017-11-08
• Completion: 2018-03-14
• First posted: 2014-07-10
• Last updated: 2023-01-04
• Results posted: 2019-02-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study