Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00153933

Run by

Dana-Farber Cancer Institute

People needed

58

Starts

2004-08-01

Expected to finish

2014-07-01

Last updated by the study team

2016-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Center — Atlanta, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Vincent's Comprehensive Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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