A Phase II Clinical Trial of Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance After Autologous Stem Cell Transplantation
- Patients must be 18 years of age or above at the time of enrollment.
- Patients must show evidence of asymptomatic relapse and/or progression of disease
(increasing M spike in serum or urine by consensus criteria) while on lenalidomide
maintenance after HDM/ASCT as part of initial line of therapy.
- Patient must have myeloma that is measurable by either serum or urine evaluation of
the monoclonal component or by assay of serum free light chains. Measurable disease
is defined as one or more of the following: serum M-protein > or = to 1 g/dl, urine
M-protein > or = to 200 mg/24 h, and/or serum FLC assay: involved FLC level > 10
mg/dL with abnormal serum FLC ratio.
- Patients must have adequate organ function including: Hepatic function with Bilirubin
<2x the upper limit of normal and ALT and AST < 3 x the upper limit of normal; renal
function with creatinine clearance > or = to 60 ml/min using the Cockcroft-Gault
formula; hematologic function as defined by an absolute neutrophil count > 1000
neutrophils per microliter, platelet > 50,000 platelets per microliter and hemoglobin
of > or = to 9 gm/dL without transfusion support
- All study participants 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)1 must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again
within 24 hours prior to prescribing lenalidomide for Cycle 1 (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 28
days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy
testing. Men must agree to use a latex condom during sexual contact with a FCBP even
if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure,
Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix
- Patients with plasma cell leukemia.
- Karnofsky performance score less than 70% or ECOG performance status greater than 2.
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking
medication and progression of clinical symptoms).
- Patients with prior malignancies except resected basal cell carcinoma or treated
cervical carcinoma in situ or other cancer treated with curative intent > 5 years
previously. Cancer treated with curative intent < 5 years previously will not be
allowed unless approved by the Protocol Chairs.
- Female patients who are pregnant (positive HCG) or breastfeeding. (Lactating females
must agree not to breast feed while taking lenalidomide)
- Patients seropositive for the human immunodeficiency virus (HIV).
- Prior organ transplant requiring immunosuppressive therapy.
- Patients who were previously exposed to higher doses of lenalidomide and who
developed severe adverse events at higher doses that preclude incremental dosing.