Back to resultsExpanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Elotuzumab
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126617
Brief Title
Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Official Title
Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Elotuzumab
Other Intervention Name(s)
Empliciti, BMS-901608
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine.html
Description
Information for Early Patient Access to Investigational Drugs
Learn more about this trial
Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
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