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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

Brief Summary:
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide, Bendamustine, Prednisone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: RBP
Lenalidomide and Bendamustine and Prednisone
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the safety of lenalidomide, bendamustine and prednisone at MTD [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01002703

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Contact: Dietger Niederwieser +4934197 ext 13050

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University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Dietger Niederwieser    +4934197 ext 13050   
Sub-Investigator: Wolfram Pönisch         
Sponsors and Collaborators
University of Leipzig
Celgene Corporation
Mundipharma Pte Ltd.

Additional Information:
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Responsible Party: Prof. Dr. med. Dr. h.c. Dietger Niederwieser, University of Leipzig Identifier: NCT01002703     History of Changes
Other Study ID Numbers: RBP-01/08
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: October 2009
Keywords provided by University of Leipzig:
Multiple Myeloma
Phase I/II
refractory Myeloma
relapsed Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Alkylating