MedTrace Logo

Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease

NCT01410500 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2017-05-02

No results posted yet for this study

Summary

The purpose of this study is to expand upon the safety data for carfilzomib by providing expanded access to patients with relapsed and refractory multiple myeloma who are unable to enroll in any other ongoing carfilzomib trial.

Conditions

Interventions

DRUG

Carfilzomib

Carfilzomib was administered as an intravenous (IV) infusion over approximately 10 minutes on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles at a dose of 20 mg/m² on Days 1 and 2 of Cycle 1 and 27 mg/m² for all infusions thereafter until Cycle 12. For Cycle 13 and higher for those still receiving carfilzomib, the carfilzomib infusion schedule was abridged to Days 1, 2, 15, and 16 of each subsequent 28-day cycle. Carfilzomib treatment was continued until disease progression, diagnosis of a new malignancy, unacceptable toxicity, withdrawal of consent, or the study was terminated

Sponsors & Collaborators

  • Multiple Myeloma Research Foundation

    collaborator OTHER

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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 NCT01410500 on ClinicalTrials.gov