Clinical trial NCT00482261 (phase 2, status: unknown status)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: lenalidomide, dexamethasone, aspirin
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, CC(=O)OC1=CC=CC=C1C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign consent form.

          2. Must meet one of following age group requirements at the time of signing consent form.

               1. age 18-59 years

               2. >59 years

          3. Patients 18-59 years are eligible only if:

               -  platelets between 50-74x109/L or

               -  calculated GFR between 20ml/min and 59ml/min

          4. Able to adhere to the study visit schedule and other protocol requirements.

          5. Subject was previously diagnosed with multiple myeloma based on standard diagnostic
             criteria.

          6. Must have relapsed or refractory disease.

          7. Measurable disease, defined as follows:

               -  For secretory multiple myeloma: measurable disease is defined as any quantifiable
                  serum monoclonal protein value (generally, but not necessarily, >5g/L of
                  M-Protein). If the M band is <5g/L, then the serum free light chains(SFLC) must
                  be assessed and if >100mg/L will also be used to measure disease response. Where
                  applicable, urine light-chain excretion of ≥200 mg/24 hours will also be used to
                  measure disease response.

               -  For light chain disease (M band in serum <5g/L but measurable FLC in urine):
                  measurable disease is defined by either urine FLC OR the presence of serum FLC
                  (must be >100mg/L). Investigators can use either test (or both) but must use the
                  same method throughout the trial.

               -  For non-secretory multiple myeloma (no M-protein in serum or urine by
                  immunofixation): measurable disease is defined by soft tissue (not bone)
                  plasmacytomas as determined by clinical examination or applicable radiographs
                  (i.e. MRI, CT-Scan).

          8. Patient has a life-expectancy ≥3 months.

          9. All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

         10. ECOG performance status of ≤2 at study entry

         11. Laboratory test results within these ranges:

               -  Absolute neutrophil count ³ 1.0 x 109/L (can be supported with growth factor)

               -  Total bilirubin ≤1.5 mg/dL

               -  AST (SGOT) or ALT (SGPT) ≤2 x UL

         12. For females subjects:

               -  Must have two negative pregnancy tests (sensitivity ≥ 50 mIU/mL) prior to
                  starting study drug. The first pregnancy test must be performed within 10-14 days
                  prior to the start of study drug and the second pregnancy test must be performed
                  within 24 hours prior to the start of study drug.

               -  Females of childbearing potential (FCBP)† must agree to use two reliable forms of
                  contraception simultaneously or to practice complete abstinence from heterosexual
                  intercourse during the following time periods related to this study: 1) for at
                  least 28 days before starting study drug; 2) while participating in the study;
                  and 3) for at least 28 days after discontinuation from the study.

         13. Male Subjects:

               -  Must agree to use a latex condom during sexual contact with females of
                  childbearing potential while participating in the study and for at least 28 days
                  following discontinuation from the study even if he has undergone a successful
                  vasectomy.

               -  Will be warned that sharing study drug is prohibited and will be counseled about
                  pregnancy precautions and potential risks of fetal exposure.

         14. Disease free of prior malignancies for ≥3 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast.

         15. Able to take aspirin daily as prophylactic anticoagulation. (patients intolerant to
             ASA may use low molecular weight heparin).

        Exclusion Criteria:

          1. Dexamethasone resistant myeloma based on last therapy. Patients are defined as being
             refractory to high-dose dexamethasone if they achieved less than a partial response,
             or developed progressive disease within 6 months of discontinuing dexamethasone, or
             dexamethasone was discontinued because of ≥Grade 3 dexamethasone-related toxicity.
             High-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over
             a 10-week period, whether administered alone or as part of the VAD regimen.

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

          3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          4. 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.

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

          6. Known hypersensitivity to thalidomide.

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

          8. Any prior use of lenalidomide.

          9. Concurrent use of other anti-cancer agents or treatments.

         10. Known positive for HIV or infectious hepatitis, type A, B or C.