CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Dexamethasone +2 moredrug
Likely dose
Dexamethasone 20 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/NCT01470196
NCT01470196Phase 2Completed

Carfilzomib, Rituximab, and Dexamethasone (CaRD) in Waldenstrom's Macroglobulinemia

Dana-Farber Cancer Institute·interventional·Posted Nov 11, 2011·Updated Nov 20, 2018

In Brief

A Phase 2 clinical trial evaluating Dexamethasone, Carfilzomib, and 1 other intervention for Waldenstrom's Macroglobulinemia. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has not been approved by the FDA. Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM), alone or in combination with other drugs. Combinations with rituximab, dexamethasone and proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients. In this research study, the investigators are testing the safety and efficacy of Carfilzomib when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's Macroglobulinemia.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.6 years ago

Interventions

Dexamethasonedrug

20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8

Carfilzomibdrug

20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8

Rituximabdrug

375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8