Clinical trial NCT00151203 (phase 2, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: clarithromycin, lenalidomide, dexamethasone
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility 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.