Status:
COMPLETED
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attac...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
- Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
- ECOG Performance Status 0, 1, or 2
- Laboratory values as outlined in the protocol
Exclusion
- Uncontrolled infection
- Cytotoxic chemotherapy \< 3 weeks, or biologic or targeted novel therapy \< 2 weeks, or corticosteroids \< 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
- Pregnant women
- Nursing women
- Men or women of child-bearing potential who are unwilling to employ adequate contraception
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
- Known to be HIV positive
- Radiation therapy \< 2 weeks prior to registration
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00903968
Start Date
June 1 2009
End Date
October 1 2016
Last Update
June 2 2020
Active Locations (5)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
3
Milford Hospital
Milford, Massachusetts, United States, 01757
4
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462