CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Selinexor +2 moredrug
Likely dose
Dexamethasone 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02186834
NCT02186834Phase 2Completed
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Investigator-Initiated Phase I/II Clinical Trial of Selinexor (KPT-330) and Liposomal Doxorubicin for Relapsed and Refractory Multiple Myeloma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jul 10, 2014·Updated Jan 4, 2023

In Brief

A Phase 2 clinical trial evaluating Selinexor, Liposomal doxorubicin, and 1 other intervention for Multiple Myeloma. Completed, enrolled 28 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsKaryopharm Therapeutics Inc

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartSep 23, 2014
Primary CompletionNov 8, 2017
Study CompletionMar 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.0 years ago

Interventions

Selinexordrug

Selinexor orally as outlined in the study treatment arm.

Liposomal doxorubicindrug

Pegylated liposomal doxorubicin at a starting dose of 20 mb/m² as outlined in the treatment arm.

Dexamethasonedrug

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.