CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 84 enrolled
Drug / intervention
Carfilzomib +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/NCT00603447
NCT00603447Phase 1Completed
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Phase 1b Multicenter Dose Escalation Study of Carfilzomib With Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma

Amgen·interventional·Posted Jan 29, 2008·Updated May 30, 2017

In Brief

A Phase 1 clinical trial evaluating Carfilzomib, Lenalidomide, and 1 other intervention for Relapsed Multiple Myeloma. Completed, enrolled 84 participants across 12 sites in 2 countries.

Detailed Summary

To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Multiple Myeloma
CountriesCanada, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2008
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2013
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.4 years ago

Interventions

Carfilzomibdrug

Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area.

Lenalidomidedrug

Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle.

Dexamethasonedrug

Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.