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

August 11, 2011 updated by: University of Leipzig

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Recruiting
        • University of Leipzig
        • Sub-Investigator:
          • Wolfram Pönisch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 month

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of lenalidomide, bendamustine and prednisone at MTD
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Mundipharma Pte Ltd.
Celgene Corporation
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBP-01/08
  • OSHO77

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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