Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1.
Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease
progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the
patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid
(prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and
prednisone are in tablet form and will be taken orally (by mouth). However, if the patient
has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will
be continued until their disease progresses. See the intervention descriptions for further
details.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Age ≥65 years or not eligible for high dose therapy and autologous stem cell
transplant

- Able to adhere to study visit schedule and other protocol requirements

- Diagnosed with multiple myeloma and considered to have active disease. Patients must
not have received an active chemotherapy regimen or Dexamethasone. Patients may have
received palliative radiotherapy at least 2 weeks prior to the study start.

- Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted
in a 24-hour urine collection sample) or by serum free light chains (involved free
light chain greater than 100mg/L)

- Eastern Cooperative Group (ECOG) Performance Status of 0 or 1

- Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the
laboratory

- Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x ULN

- Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x
10^9/L); Platelets ≥ 100,000 /mm³

- Hemoglobin > 8 g/dL

- Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault
formula

- Low risk myeloma is defined as the absence of the following adverse features[21]:
t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase
cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy by
metaphase analysis; Β2 microglobulin > 5.5.

- Able to tolerate one of the following thromboprophylactic strategies: aspirin, low
molecular weight heparin or warfarin (coumadin)

- Must be registered into the mandatory RevAssist® program, and be willing and able to
comply with the requirements of RevAssist®.

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 milli-international units per milliliter
(mIU/mL) within 10 14 days prior to and again within 24 hours of prescribing
lenalidomide (prescriptions must be filled within 7 days) and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 4 weeks before taking lenalidomide. FCBP must also agree to
ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact
with a female of child bearing potential even if they have had a successful vasectomy.

Exclusion Criteria:

- Ongoing severe infection requiring intravenous antibiotic treatment

- Life expectancy of less than 3 months

- Performance status of 2, 3 or 4

- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in-situ cervical cancer, or other cancer from which the patient has been
disease-free for at least 2 years

- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia

- Uncontrolled medical problems such as diabetes mellitus, congestive heart failure,
coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary,
hepatic and renal diseases unless renal insufficiency is felt to be secondary to
multiple myeloma.

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or lactating

- Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

- Known hypersensitivity to thalidomide

- Use of any other experimental drug or therapy within 28 days of baseline.

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Any prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine are eligible.