MedTrace Logo

A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma

NCT01660750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-10-18

No results posted yet for this study

Summary

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma.

Conditions

Interventions

DRUG

Carfilzomib

IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days

DRUG

Cyclophosphamide

PO on days 1, 8, and 15 every 28 days

DRUG

Dexamethasone

40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Jatin Shah, MD · AMyC

  • Brian GM Durie, MD · AMyC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660750 on ClinicalTrials.gov