Clinical trial NCT00306813 (phase 1/phase 2, status: completed)
Conditions: relapse, refractory multiple myeloma
ICD codes: C90.02, C90.22, C90.32, C92.32, C95.92, C90.12, C91.02, D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22
Drugs: revlimid
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for enrollment
        into the study

          1. Understand and voluntarily sign an informed consent form.

          2. Age > 18 years at the time of signing the informed consent form.

          3. Multiple myeloma with Durie-Salmon stage II or III and considered to have disease
             progression after at least 1 previous anti-myeloma regimen (examples: induction
             chemotherapy followed by stem cell collection and high dose chemotherapy and
             autologous PBSCT; MP; anthracycline-containing regimen > 3 months ago, any other
             conventional regimen including thalidomide- or bortezomib containing regimens.

          4. Subjects must have not have recieved more than 3 previous anti-myeloma regimens and
             must be relapsed or refractory following at least one regimen of anti-myeloma therapy.

          5. No anthracycline-containing regimen (e.g. VAD) within the last 3 months of study.

          6. Subjects may have been previously treated with thalidomide or bortezomib.

          7. Radiation therapy after start of the protocol will be considered as treatment failure
             except when given to treat pathological fractures or preexisting osteolytic lesions.

          8. Patients must have measurable levels of myeloma paraprotein in serum (>0.5 g/dl) or
             urine (>0.2 g excreted in a 24-hour collection sample).

          9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

         10. Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days of starting each cycle. Men and WCBP must agree to use adequate
             contraceptive methods.

         11. Must have a 2-d echocardiogram indicating LVEF ≥ 55% within 42 days prior to first
             dose of study drug.

         12. Life extpectancy > 3 months.

        Exclusion criteria:

        The presence or any of the following will exclude a subject from study enrollment.

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             makes the patient ineligeble for the study. Uncontrolled medical problems such as
             diabetes mellitus, coronary artery disease, hypertension, unstable angina,
             arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt
             to be secondary to multiple myeloma.

          2. Pregnant or lactating females.

          3. Heart failure (EF < 55%).

          4. Any of the following laboratory abnormalities Absolute neutrophil count (ANC)
             <1500/mm3 (1x109/L) Platelet count (PLT) <100000/mm3 Serum creatinine> 2.5 mg/dL SGOT
             and SGPT > 3 x upper limit of normal (ULN) Serum total bilirubin >1.2 mg/dL

          5. Prior history of any other malignancies except for adequately treated basal cell,
             insitu cervical or breast cancer or other for which the patient has been disease free
             for 5 years.

          6. Known hypersensitivity to thalidomide, dexamethasone and/or anthracyline.

          7. Prior use of Revlimid.

          8. Anthracycline-containing regimen (e.g. VAD) within the last 3 months of study.

          9. Any history of thrombembolic events

         10. Use of any standard or experimental anti-myeloma drug therapy within 28 days of study
             enrolment.

         11. Major surgery or radiotherapy within 4 weeks of study enrolment.

         12. Active infection requiring antibiotic therapy.

         13. Subjects who have received > 300 mg/m2 lifetime cumulative dose of doxorubicin alone,
             or Doxil® alone, or doxorubicin plus Doxil®.

         14. History of cardiac disease, with New York Heart Association Class II or greater (See
             Appendix VII).

         15. Known HIV or hepatitis B or C positive.

         16. No more than 3 prior anti-myeloma regimens.