A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma
1. Previously diagnosed with multiple myeloma.
2. Must have relapsed or refractory disease (refractory is defined as progression during
treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd
3. Patients may have received lenalidomide and/or dexamethasone
4. Patients must have measurable disease:
- Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
- Patients with lower M-protein values or non-secretory myeloma will be eligible
if measurable disease can be established, such as serum FreeliteTM chain ratio
>5x ULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/or
applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
5. Age >=18 years at the time of consent.
6. All necessary baseline studies for determining eligibility must be obtained within 14
days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL),
for females of childbearing potential (WCBP) must be completed. The first test must
be performed within 10-14 days, and the second test within 24 hours prior to
initiation of lenalidomide.
7. Pre-study ECOG performance status 0-2. Patients with lower performance status based
solely on bone pain will be eligible.
8. Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN,
except if attributed to tumor, and bilirubin =< 2xULN.
9. Have Amylase =< 2.5x ULN
10. Able to adhere to the study visit schedule and other protocol requirements
11. Must understand and voluntarily sign an informed consent document.
12. Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and
again within 24 hours of starting lenalidomide 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 she starts taking lenalidomide. FCBP must also agree
to ongoing pregnancy testing. Men must agree not to father a child and agree to use
a condom if his partner is of child bearing potential. All patients must be
counseled at a minimum of every 28 days about pregnancy precautions and risks of
13. All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®. All counseling
will be done through RevAssist®.
14. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients
intolerant to ASA may use low molecular weight heparin. Lovenox is recommended.
Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to
15. Patients may receive a bisphosphonate.
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females.(Lactating females must agree not to breast feed
while taking lenalidomide).
3. 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.
4. Renal insufficiency of creatinine clearance <40mL/min
5. Known hypersensitivity to thalidomide or lenalidomide.
6. Development of erythema nodosum if characterized by a desquamating rash while taking
thalidomide or similar drugs.
7. Concurrent use of other anti-cancer agents or treatments.
8. Known seropositive for an 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.
9. Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet
eligibility criteria will not be allowed.
10. Has an absolute neutrophil count <1.0x10^9/L within 14 days before enrollment
11. Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also
12. Has platelet count <75x10^9/L within 14 days before enrollment.
13. Plasma cell leukemia at time of study entry.