Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

Inclusion Criteria:

Pathologically confirmed multiple myeloma

Measurable levels of M protein in serum and/or urine

Recurrent or refractory disease

Progressive disease after treatment with ≥ 2 separate chemotherapeutic regimens

At least 1 of the regimens must have included high-dose dexamethasone (40 mg on days 1-4, 9-12, and 17-20) or medium-dose dexamethasone (40 mg on days 1, 8, 15, and 22) of a 28-day course
ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
Life expectancy ≥ 8 weeks
Absolute neutrophil count > 1,000/mm^3
Platelet count > 100,000/mm ^3
Total bilirubin < 2 mg/dL
AST and ALT < 3 times upper limit of normal
Creatinine < 2 mg/dL
Fasting cholesterol < 350 mg/dL
Fasting triglycerides < 400 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus or dexamethasone

No concurrent uncontrolled illness including, but not limited to, any of the following:

Ongoing or active infection
Poorly controlled hypertension
Diabetes mellitus
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with study requirements
See Disease Characteristics
At least 4 weeks since prior cytotoxic therapy
More than 4 weeks since prior chemotherapy and recovered
No concurrent anticonvulsive or antiarrhythmic medications
No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) or other CYP3A4 inhibitors or inducers (e.g., rifampin or Hypericum perforatum [St. John wort])
No concurrent prophylactic hematopoietic colony-stimulating factors
No other concurrent investigational therapy
No other concurrent anticancer therapy