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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2009 by University of Leipzig
Sponsor:
Collaborators:
Celgene Corporation
Mundipharma Pte Ltd.
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
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide, Bendamustine, Prednisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the safety of lenalidomide, bendamustine and prednisone at MTD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002703

Contacts
Contact: Dietger Niederwieser +4934197 ext 13050 dietger@medizin.uni-leipzig.de

Locations
Germany
University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Dietger Niederwieser    +4934197 ext 13050    dietger@medizin.uni-leipzig.de   
Sub-Investigator: Wolfram Pönisch         
Sponsors and Collaborators
University of Leipzig
Celgene Corporation
Mundipharma Pte Ltd.
Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. Dr. h.c. Dietger Niederwieser, University of Leipzig
ClinicalTrials.gov Identifier: NCT01002703     History of Changes
Other Study ID Numbers: RBP-01/08, OSHO77
Study First Received: October 23, 2009
Last Updated: August 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
Lenalidomide
Bendamustine
Multiple Myeloma
Myeloma
Revlimid
Phase I/II
refractory Myeloma
relapsed Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Bendamustine
Lenalidomide
Nitrogen Mustard Compounds
Thalidomide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 11, 2014