Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077
1. Understand and voluntarily sign an informed consent form.
2. Age 18 years at the time of signing the informed consent form.
3. Life expectancy of at least 3 months
4. Able to adhere to the study visit schedule and other protocol requirements
5. Relapsed or refractory MM (only first or second relapse) in stage II or III after
autologous SCT or conventional chemotherapy (histologically or cytologically proven/
Salmon and Durie criteria) with detectable myeloma protein in blood or urine
6. All previous cancer therapies, including radiation, cytostatic therapy and surgery,
must have been discontinued at least 4 weeks prior to treatment in this study,
without corticosteroids therapy.
7. ECOG performance status of £ 2 at study entry (see Appendix 01).
8. Laboratory test results within ranges
9. Females of childbearing potential must agree to contraception or abstinence
10. Disease free of prior malignancies for ³ 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding 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. Patients with contraindications (exclusion criteria) for treatment with lenalidomide,
bendamustine and prednisone.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarction within
6 months before study entry, New York Heart Association Class III or IV heart
failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown
6. Use of any other experimental drug or therapy within 28 days of baseline.
7. Known hypersensitivity to thalidomide or purine analogues
8. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
9. Any prior use of lenalidomide or bendamustine in the last six months
10. Concurrent use of other anti-cancer agents or treatments other stated in this
11. Known positive for HIV or infectious hepatitis, type A, B or C.