Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: lenalidomide
Intervention description: patients will begin therapy with lenalidomide 25 mg daily, 21 days out of a 28 day schedule. All patients will be evaluated monthly after every cycle. The dose will be adjusted downward in response to side effects and according to specific guidelines. Symptomatic POD occurring at any time during the study will result in removal of the patient from the study. After 2 cycles of lenalidomide, patients with at least stable disease (SD) will continue lenalidomide indefinitely until asymptomatic POD, at which time dexamethasone will be added at a dose of 40mg weekly. On the other hand, patient with asymptomatic POD after 2 cycles of lenalidomide will have dexamethasone added at a dose of 40 mg weekly. Patients with any type of POD after any cycle that includes dexamethasone will be taken off study. Patients can remain on study on lenalidomide or lenalidomide/dexamethasone indefinitely as long as they do not have POD as stated above and they tolerate the treatment.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LENALIDOMIDE (CC-5013); BONE MARROW; 11-107

Summary:

      The purpose of this study is to determine whether this disease will get better if treated
      with higher doses of Lenalidomide even if the disease returns while taking low doses of
      Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the
      disease will return. However, the physician currently does not know if the disease would
      respond to treatment with higher doses of Lenalidomide. This is very important for patients
      with multiple myeloma because the number of drugs available to treat the disease are limited.
      It is important to know if Lenalidomide remains still effective and if it can still be used
      in this situation. This study will try to find out what effects, good and/or bad higher doses
      of Lenalidomide has on the patient and the disease after it has returned.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Patients who have not had an HDM/ASCT as part of initial line of therapy but who are
             on continuous/maintenance lenalidomide after initial therapy will be permitted on
             study.

          -  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 ≥ to 0.5 g/dl, urine
             M-protein ≥ 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 ≥ 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 ≥ 9 gm/dL
             without transfusion support

          -  All study participants must be registered into the mandatory Revlimid REMS® program,
             and be willing and able to comply with the requirements of the REMS® program.

          -  Females of child bearing potential (FCBP) must adhere to the scheduled pregnancy
             testing as required in the Revlimid REMS® program

          -  FCBP 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.

        Exclusion Criteria:

          -  Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix
             A).

          -  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.