CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Carfilzomibdrug
Likely dose
Carfilzomib 56mg/m2from 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/NCT01351623
NCT01351623Phase 2Completed

Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

Memorial Sloan Kettering Cancer Center·interventional·Posted May 11, 2011·Updated Apr 13, 2017

In Brief

A Phase 2 clinical trial evaluating Carfilzomib for Multiple Myeloma. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The purpose of this study is to test a new drug called carfilzomib. It is a type of drug called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells make a lot of protein and are especially in need of a functional proteasome to survive. Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It is considered an experimental drug. Previous studies have shown that carfilzomib is safe to use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2011
Enrollment StartMay 9, 2011
Primary CompletionJan 26, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.1 years ago

Interventions

Carfilzomibdrug

Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.