Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002703
Recruitment Status : Unknown
Verified October 2009 by University of Leipzig.
Recruitment status was:  Recruiting
First Posted : October 27, 2009
Last Update Posted : August 12, 2011
Celgene Corporation
Mundipharma Pte Ltd.
Information provided by:
University of Leipzig

October 23, 2009
October 27, 2009
August 12, 2011
September 2009
October 2012   (Final data collection date for primary outcome measure)
To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III [ Time Frame: 2 month ]
Same as current
Complete list of historical versions of study NCT01002703 on Archive Site
To determine the safety of lenalidomide, bendamustine and prednisone at MTD [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma
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
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: Lenalidomide, Bendamustine, Prednisone
During the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine.
Experimental: RBP
Lenalidomide and Bendamustine and Prednisone
Intervention: Drug: Lenalidomide, Bendamustine, Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2014
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  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 or breast

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 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 3).
  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 treatment plan.
  11. Known positive for HIV or infectious hepatitis, type A, B or C.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Prof. Dr. med. Dr. h.c. Dietger Niederwieser, University of Leipzig
University of Leipzig
  • Celgene Corporation
  • Mundipharma Pte Ltd.
  • Amgen
Not Provided
University of Leipzig
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP