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

This study is currently recruiting participants.
Verified October 2009 by University of Leipzig
Sponsor:
Collaborators:
Celgene Corporation
Mundipharma
Amgen
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT01002703
First received: October 23, 2009
Last updated: August 11, 2011
Last verified: October 2009
History of Changes

October 23, 2009
August 11, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01002703 on ClinicalTrials.gov Archive Site
To determine the safety of lenalidomide, bendamustine and prednisone at MTD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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.
Both
18 Years and older
No
Contact: Dietger Niederwieser +4934197 ext 13050 dietger@medizin.uni-leipzig.de
Germany
 
NCT01002703
RBP-01/08, OSHO77
Yes
Prof. Dr. med. Dr. h.c. Dietger Niederwieser, University of Leipzig
University of Leipzig
  • Celgene Corporation
  • Mundipharma
  • 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