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NCT02666209 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02666209
Other study ID # 16-002
Secondary ID CA212-122
Status No longer available
Phase N/A
First received January 22, 2016
Last updated August 25, 2017

Study information
Verified date August 2017
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ulocuplumab
CXCR4 inhibitor given weekly on a 28 day cycle intravenously
• Lenalidomide
immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
• Bortezomib
proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
• Dexamethasone
steroid given at physician discretion on a 28 day cycles

Locations
Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

See also
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1