Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma

Relapsed or refractory disease requiring treatment

Measurable disease, as defined by at least 1 of the following:

Serum monoclonal protein ≥ 1.0 g
More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Monoclonal bone marrow plasmacytosis ≥ 30% (i.e., evaluable disease)
No known standard therapy that is potentially curative for the patient's disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 12 weeks
ANC ≥ 1,000/μL
Platelet count ≥ 75,000/μL
Hemoglobin ≥ 9 g/dL
Direct bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 3 times ULN (≤ 5 times ULN if the liver is involved)
Creatinine ≤ 2.5 times ULN
Patients with treated or untreated POEMS (Patient-Oriented Evidence That Matters) allowed, provided they satisfy the criteria for measurable disease
No other prior malignancy within the past year except currently treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or prostate cancer not requiring therapy
No other active malignancy requiring treatment that would interfere with the assessments of response of the myeloma to protocol treatment

INR < 1.5 OR PT/PTT ≤ 1.5 times ULN

Patients receiving anticoagulation treatment with an agent such as warfarin or heparin are allowed
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of effective contraception for 28 days prior, during, and for 28 days after discontinuation of lenalidomide
Willing to provide research samples according to the test schedule
No uncontrolled infection
No NYHA classification III or IV heart disease
No unstable angina (i.e., anginal symptoms at rest), new-onset angina (i.e., began within the past 3 months), or myocardial infarction within the past 6 months
No uncontrolled hypertension, defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
No thrombotic or embolic events within the past 6 months, including cerebrovascular accidents and transient ischemic attacks
More than 4 weeks since prior pulmonary hemorrhage or other bleeding event > grade 2
No serious nonhealing wound or ulcer
More than 4 weeks since prior significant traumatic injury
No known positivity for HIV infection or infectious hepatitis, type A, B, or C
No known hypersensitivity to thalidomide or lenalidomide
No prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Able to take aspirin (325 mg) daily as prophylactic anticoagulation

PRIOR CONCURRENT THERAPY:

Recovered from prior chemotherapy, regardless of interval since last treatment
Prior lenalidomide therapy allowed
More than 4 weeks since prior experimental therapy
More than 4 weeks since prior major surgery or open biopsy
No concurrent enrollment in any other study involving a pharmacologic agent or investigative therapy (i.e., drug, biologic, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent
No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin, carbamazepine, and phenobarbital), rifampin, or Hypericum perforatum (St. John wort)