A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma
- 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
- 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
- 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)
- 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
- 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
- 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.