Status:
UNKNOWN
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Celgene Corporation
Mundipharma Pte Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
Eligibility Criteria
Inclusion
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Life expectancy of at least 3 months
- Able to adhere to the study visit schedule and other protocol requirements
- 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
- 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.
- ECOG performance status of £ 2 at study entry (see Appendix 01).
- Laboratory test results within ranges
- Females of childbearing potential must agree to contraception or abstinence
- 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 or breast
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- 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.
- Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
- 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 3).
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide or purine analogues
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide or bendamustine in the last six months
- Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01002703
Start Date
September 1 2009
End Date
October 1 2014
Last Update
August 12 2011
Active Locations (1)
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1
University of Leipzig
Leipzig, Germany, 04103