CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Cohort 1: Carfilzomib 15 mg/m2 +3 moredrug
Likely dose
Cohort 1: Carfilzomib 15 mg/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/NCT02148913
NCT02148913Phase 1Completed

A Phase I Study of Melphalan, Bendamustine, and Carfilzomib for Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma

Corewell Health West·interventional·Posted May 28, 2014·Updated Jul 26, 2024

In Brief

A Phase 1 clinical trial evaluating Cohort 1: Carfilzomib 15 mg/m2, Cohort 2: Carfilzomib 20 mg/m2, and 2 other interventions for Multiple Myeloma. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing autologous transplantation will receive a preparative regimen of melphalan, bendamustine, and carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen of melphalan and bendamustine in the setting of autologous transplantation for multiple myeloma is feasible and safe.

Study Details

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

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 28, 2014
Enrollment StartJun 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.1 years ago

Interventions

Cohort 1: Carfilzomib 15 mg/m2drug

Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6

Cohort 2: Carfilzomib 20 mg/m2drug

Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6

Cohort 2b: Carfilzomib 20 mg/m2drug

Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5

Cohort 3b: Carfilzomib 27 mg/m2drug

Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5