Status:
COMPLETED
Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose if this study is to evaluate the side effects of the combination of bortezomib and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.
Detailed Description
* Within 21 days of starting treatment the following tests will be performed: physical exam (including vital signs), ECG, neurological examination, blood tests, urine tests, bone marrow aspiration, x-...
Eligibility Criteria
Inclusion
- Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
- Must have relapsed or relapsed/refractory disease
- 18 years of age or older
- All baseline studies must be performed within 21 days of enrollment.
- ECOG performance status of 0 to 2
Exclusion
- Renal insufficiency (serum creatinine levels \> 2mg/dL)
- Concomitant therapy medications that include corticosteroids
- Peripheral neuropathy of Grade 3 or greater or painful Grade 2
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC \< 1000 cells/mm3
- Hemoglobin \< 8.0 g/dL
- AST (SGOT and ALT) \> 2 x ULN
- Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
- Known hypersensitivity to thalidomide or the development of erythema nodosum
- Active infection or serious co-morbid medical condition
- Pregnant or breast-feeding women
- Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00153933
Start Date
August 1 2004
End Date
July 1 2014
Last Update
January 25 2016
Active Locations (6)
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1
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Winship Cancer Center
Atlanta, Georgia, United States, 30322
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115