Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03126617
Expanded Access Status : Available
First Posted : April 24, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:

At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.

When contacted by a treating physician, BMS will consider requests for providing early patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium, Thailand, Turkey, Argentina, and Colombia.


Condition or disease Intervention/treatment
Multiple Myeloma Biological: Elotuzumab

Detailed Description:

Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to participate in an early patient access program.

To learn more about early patient access programs, your doctor may contact BMS using the information provided below.


Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma



Intervention Details:
  • Biological: Elotuzumab
    Elotuzumab (Emplicitii) is a Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) directed immunostimulatory antibody approved by the US Food and Drug Administration (FDA) and indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Please contact your physician for more details.
    Other Names:
    • Empliciti
    • BMS-901608

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Specific eligibility criteria must be met for access outside of a clinical trial.

These inclusion criteria include:

  • The illness must be serious or life threatening
  • There are no other viable options (including approved products or active clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
  • Other defined inclusion/exclusion criteria could be applicable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126617


Contacts
Layout table for location contacts
Contact: Bristol-Myers Squibb, Study Director Please email: Clinical.Trials@bms.com

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03126617     History of Changes
Other Study ID Numbers: EAP-01-CA204
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Elotuzumab
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents