Multiple Myeloma Clinical Trial
Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
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.
Full Description
The safe dose of dexamethasone is already known. The dose of bortezomib and lenalidomide will be increased during the study until the best and safest amount (or dose) is identified. The participant's dose of the study drugs will depend on when they enter the study.
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
During the course of the study treatment, tests and procedures will be performed at designated time periods. This includes; medical history updates, physical/neurological examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).
It is expected that study participants will receive study treatment for 8 cycles (168 days). If the participant completes the first 8 cycles of the study, has stable or responding disease and has not experienced bad side effects, they will be allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
Eligibility 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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
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