Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma

August 25, 2017 updated by: Irene Ghobrial, MD, Dana-Farber Cancer Institute
Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent document
  • Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

Exclusion Criteria:

  • Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Irene M Ghobrial, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-002
  • CA212-122 (Other Identifier: Bristol-Myers Squibb)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Ulocuplumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe