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RECRUITING
NCT03909412
PHASE1

Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

Summary

This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg/m2, 27mg/m2, 36mg/m2, 45mg/m2, 56mg/m2, and 70mg/m2 to be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)

Official title: Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2019-10-08

Completion Date

2026-09

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DRUG

Carfilzomib

Carfilzomib will be administered over 10 minutes for the 20 mg/m2 and 27 mg/m2 dose and over 30 minutes for all higher doses.

DRUG

Cyclophosphamide

Cyclophosphamide dosed at 2gm/m2 administered over 1 hour.

DRUG

Dexamethasone

Dexamethasone 40mg IV/PO to be administered as a premedication.

DRUG

Granulocyte Colony-Stimulating Factor

On day 7 subjects will initiate high dose G-CSF injections at 14mcg/kg daily (with a cap of 1440mcg daily).

Locations (1)

Hackensack Meridian Health - John Theurer Cancer Center

Hackensack, New Jersey, United States