| Inclusion Criteria: | 1) Symptomatic multiple myeloma
2) Relapsed or progressive disease after at least one but no more than three prior therapeutic treatments or regimens for multiple myeloma.
3) Prior therapeutic treatment regimens may include bortezomib, lenalidomide, and/or thalidomide, among other agents.
4) If previously treated with lenalidomide or bortezomib, the subject must not have progressed during the first 3 months of treatment with the drug and must not have discontinued treatment due to lenalidomide intolerance (bortezomib intolerant subjects may enroll).
5) Measureable disease, as indicated by one or more of the following: 1.) Serum M-protein greater or equal to 0.5 g/dL; 2.) Urine Bence-Jones protein greater or equal to 200 mg/24 hours; 3.) If Serum Protein Electrophoresis is felt to be unreliable for routine M-protein measurement (particularly for patients with IgA MM), then quantitative immunoglobulin levels can be accepted.
6) Prior to enrollment, sites must provide evidence of myeloma progression/relapse, with start and stop dates of the most recent treatment regimen, as well as best tumor response to all prior treatment regimens.
7) Males and females greater or equal to 18 years of age.
8) Life expectancy of more than three months.
9) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
10) Adequate hepatic function, with bilirubin less than 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) less than 3 times ULN.
11) Absolute neutrophil count (ANC) greater or equal to 1,000/mm^3; Hemoglobin greater or equal to 8 gm/dL; Platelet count greater or equal to 50,000/mm^3; (>/= 30 x 10^9/L if myeloma involvement in the bone marrow is > 50%)
12) Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks; Subjects may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines; Screening platelet count should be independent of platelet trnsfunsions for at least 2 weeks.
13) Calculated or measured creatinine clearance of equal to or greater than 50 mL/minute, calculated using the formula of Cockcroft and Gault [(140 minus Age) x Mass (kg) / (72 x creatinine mg/dL)]. Multiple result by 0.85 if female. Other generally accepted calculation methods can by substituted.
14) Written informed consent in accordance with federal, local, and institutional guidelines.
15) Females of childbearing potential (FCBP)* must agree to ongoing pregnancy testing.
16) FCBP must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 10-14 days prior (US/RevAssist) or 25 mIU/mL within 7-14 days (Canada/RevAid) prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or to use two methods of reliable birth control, including at least one highly effective method AND one additional effective method of birth control (contraception) AT THE SAME TIME,
17) (continuation of #16) beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during therapy delay, and continuing for 4 weeks following discontinuation of lenalidomide therapy. If a hormonal method (birth control pills, injections, patch or implants) or IUD is not medically possible for the subject, the subject may use another highly effective method or two barrier methods AT THE SAME TIME.
18) (continuation of # 17) * Females of childbearing potential (FCBP): Defined as sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months), or had a bilateral oophorectomy are considered to be females of childbearing potential.
19) Male subject must agree to NEVER have unprotected sexual contact with a female who can become pregnant and must agree to either completely abstain from sexual contact with females who are pregnant or able to become pregnant, or he must use a latex condom EVERY TIME he engages in any sexual contact
20) (continuation of #19) with females who are pregnant or may become pregnant while he is taking lenalidomide and for 4 weeks after he stops taking the drug, even if he has had a successful vasectomy. The subject must agree to inform his physician if he has had unprotected sexual contact with a female who can become pregnant or if he thinks FOR ANY REASON, that his sexual partner may be pregnant.
21) Male subjects cannot donate semen or sperm while taking lenalidomide
22) All study participants must be registered into the mandatory Rev Assist or RevAid program and be willing and able to comple with the requirements of Rev Assist or RevAid.
23) Subjects must adhere to the study visit schedule and other protocol requirements and receive outpatient treatment and laboratory monitoring at the institute that administers the drug
24) Subjects must agree to take enteric-coated aspirin 81-325 mg orally daily, or if history of prior thrombotic disease or allergy to aspirin, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE). |