CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Carfilzomib +1 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/NCT01677858
NCT01677858Phase 2Completed
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A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma

Amgen·interventional·Posted Sep 3, 2012·Updated Sep 23, 2022

In Brief

A Phase 2 clinical trial evaluating Carfilzomib and Dexamethasone for Multiple Myeloma. Completed, enrolled 116 participants across 35 sites.

Detailed Summary

The study had the following primary objectives: * Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies * Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib and dexamethasone QW at the MTD established in phase 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2012
Enrollment StartJul 4, 2012
Primary CompletionJul 22, 2016
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.8 years ago

Interventions

Carfilzomibdrug

Carfilzomib was administered as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day treatment cycle.

Dexamethasonedrug

Dexamethasone was administered at a dose of 40 mg IV or orally (PO) on days 1, 8, 15, and 22 for the first 8 cycles; starting with cycle 9 dexamethasone was administered on days 1, 8, and 15.