A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
- Must understand and voluntarily sign an informed consent form.
- Must be ≥18 years of age at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles
of anti-myeloma treatment or that has relapsed with progressive disease after
- Subjects may have been previously treated with thalidomide and/or radiation therapy.
In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given
concurrently with study therapy, provided that all other eligibility criteria are
- Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the
first dose of study drug with the exception of radiation therapy initiated prior to
or at baseline (Day 1).
- Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g
excreted in a 24-hour collection sample).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Females of childbearing potential (FCBP) must agree to use two reliable forms of
contraception simultaneously or to practice complete abstinence from heterosexual
intercourse during the following time periods related to this study: 1) for at least
28 days before starting study drug; 2) while participating in the study; and 3) for
at least 28 days after discontinuation from the study.
- The presence of any of the following will exclude a subject from study enrollment:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
- Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone
marrow nucleated cells are plasma cells.
- Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom ≥50% of bone marrow
nucleated cells are plasma cells.
- Serum creatinine >2.5 mg/dL (221 µmol/L)
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- Serum total bilirubin >2.0 mg/dL (34 µmol/L)
- Prior history of malignancies other than multiple myeloma (except for basal cell or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
unless the subject has been free of the disease for ≥1 year.
- Prior history of stroke and/or thromboembolic event
- Known hypersensitivity to thalidomide or dexamethasone.
- Prior history of uncontrollable side effects to dexamethasone therapy.
- The development of a desquamating rash while taking thalidomide.
- Neuropathy ≥ Grade 2.