Modified Bortezomib-based Combination Therapy for Multiple Myeloma

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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