Expired Study
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New York, New York 10021


Purpose:

PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). - To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES - To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. - To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.


Criteria:

Inclusion Criteria: - Subject must voluntarily sign and understand written informed consent. - Histologically confirmed Durie-Salomon stage II or III MM (see Appendix II). Stage I MM patients will be eligible if they display poor prognostic factors (ß2M > or = 5.5 mg/L, plasma cell proliferation index > or = 5%, albumin of less then 3.0, and unfavorable cytogenetics). - Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s). - Age > or = 18 years at the time of signing the informed consent form. - Karnofsky performance status > or = 70% (>60% if due to bony involvement of myeloma (see Appendix V). - No prior treatment or less than one full course of first-line therapy. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care. - If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study. - Due to the unknown risk of teratogenic side effects, subjects (women and men) must agree to use effective contraception throughout the duration of the study and for at least 1 month after discontinuation of study drugs. - Life expectancy > 3 months - Absolute neutrophil count (ANC)> or = 1000 cells/mm3 (1.0 x 109/L) - Platelets count > or = 75,000/mm3 (75 x 109/L) - Serum SGOT/AST < 3.0 x upper limits of normal (ULN) - Serum SGPT/ALT < 3.0 x upper limits of normal (ULN) - Serum creatinine < 2.5 mg/dL (221 µmol/L) - Serum total bilirubin < 2.0 mg/dL (34 µmol/L) Exclusion Criteria: - Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine). - Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years. - NYHA Class III or IV heart disease. History of active angina, congestive heart disease, or myocardial infarction within 6 months. - Pregnant or lactating women are ineligible. - Known HIV positivity - Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program. - Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide. - Prior therapy for the treatment of MM - History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin are eligible.


NCT ID:

NCT00151203


Primary Contact:

Principal Investigator
Ruben Niesvizky, MD
Weill Medical College of Cornell University


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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