Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: lenalidomide; dexamethasone
Intervention description: Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone; Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1913.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; MM; Revlimid; CC5013; celgene; cc-5013; relapsed/refractory; lenalidomide; dexamethasone; Decadron

Summary:

      Subjects who qualify for participation will receive lenalidomide with or without
      dexamethasone in 4 week cycles until disease progression is documented or lenalidomide
      becomes commercially available for the indication of multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must understand and voluntarily sign an informed consent form.

          2. Must be > or = to 18 years of age at the time of signing the informed consent form.

          3. Must be able to adhere to the study visit schedule and other protocol requirements.

          4. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of
             anti-myeloma treatment or that has relapsed with progressive disease after treatment.

          5. Subjects may have been previously treated with thalidomide and/or radiation therapy.
             In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given
             concurrently with study therapy, provided that all other eligibility criteria are
             satisfied.

          6. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g
             excreted in a 24-hour collection sample).

          7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

          8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
             test within 7 days of starting study drug. In addition, sexually active WCBP must
             agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) while on study medication.

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Pregnant or lactating females.

          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. Any of the following laboratory abnormalities:

               1. Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L)

               2. Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone
                  marrow nucleated cells are plasma cells.

               3. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow
                  nucleated cells are plasma cells.

               4. Serum creatinine >2.5 mg/dL (221 mmol/L)

               5. Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or
                  serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT]) >3.0 x
                  upper limit of normal (ULN)

               6. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

          5. Prior history of malignancies other than multiple myeloma (except for basal cell or
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
             unless the subject has been free of the disease for >/= 1 year.

          6. Known hypersensitivity to thalidomide or dexamethasone.

          7. Prior history of uncontrollable side effects to dexamethasone therapy.

          8. The development of a desquamating rash while taking thalidomide.

          9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of the
             initiation of study drug treatment or use of any experimental non-drug therapy (e.g.,
             donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study
             drug treatment.