Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Status: | Available |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/17/2016 |
Contact: | Irene M Ghobrial, MD |
Email: | Irene_Ghobrial@dfci.harvard.edu |
Phone: | 617-632-4198 |
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
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
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.
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.
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).
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Irene M Ghobrial, MD
Phone: 617-632-4198
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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