Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Celgene Corporation; Massachusetts General Hospital; Millennium Pharmaceuticals, Inc.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria

• Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma

• Negative serum or urine pregnancy test

• Age 18 years or older

• Karnofsky performance status of greater or equal to 60

Exclusion Criteria:

• Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment

• Renal insufficiency (serum creatinine >2.5 mg/dL)

• Evidence of mucosal or internal bleeding and/or platelet refractory

• ANC (absolute neutrophil count)< 1000 cells/mm3

• Hemoglobin < 8.0 g/dL

• AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than or equal to 2 x ULN (upper limit of normal)

• Concomitant therapy medications that include corticosteroids

• Myocardial infarction within 6 months prior to enrollment according to NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

• Clinically relevant active infection or serious co-morbid medical conditions

• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer

• Pregnant or breast-feeding

• Serious medical or psychiatric illness likely to interfere with participation in study

• Uncontrolled diabetes mellitus

• Hypersensitivity to acyclovir or similar anti-viral drug

• POEMS syndrome

• Known HIV infection

• Known active hepatitis B or C viral infection

• Known intolerance to steroid therapy