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Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Sponsor:
Information provided by (Responsible Party):
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier:
NCT00891384
First received: April 24, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

This trial is a randomised, parallel-group, multicenter phase III study for maintenance therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose therapy and autologous stem cell transplantation as first line therapy.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH:

Primary Outcome Measures:
  • event-free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety, tolerability and feasibility [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Improvement of remission rate [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • evaluate quality of life [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: April 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25 mg lenalidomide
Drug: Lenalidomide
Patients will receive maintenance therapy according to their assigned treatment arm: 25 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression.
Other Name: Revlimid
Experimental: 2
5 mg lenalidomide
Drug: Lenalidomide
Patients will receive maintenance therapy according to their assigned treatment arm:5 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression
Other Name: Revlimid

Detailed Description:

High-dose therapy will be performed as first line treatment. After high-dose therapy and autologous stem cell transplantation the patients will be included and randomised. Three month after high-dose therapy all patients will receive consolidation therapy with 6 cycles of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive maintenance therapy according to their assigned treatment arm. Randomisation will be performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Age 18-75 years
  • Able to adhere to the study visit schedule and other protocol requirements
  • Patients with multiple myeloma who have received high-dose therapy and autologous stem cell transplantation as first-line therapy within the last 90 - 120 days and have not shown progressive disease afterwards.
  • Patients may have received up to 6 cycles of prior induction therapy and up to 2 cycles of prior mobilisation chemotherapy. A bortezomib or thalidomide induction therapy is allowed. Patients may also have received prior radiation therapy
  • Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g/24hours) or measurable free light chains (FLC) in serum (>50 mg/l) with an abnormal FLC ratio must be documented at the time of first diagnosis.
  • ECOG performance status = 2 at study entry
  • Laboratory and functional test results within these ranges:

    • ANC ≥ 1,000/μL
    • Platelet count ≥ 100,000/μL
    • Total bilirubin 2.5 mg/dL
    • AST (SGOT) and ALT (SGPT) 3 x ULN
    • Patients with impaired renal function can be included
  • The patient must be able to adhere to the pregnancy precautions
  • Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or breast feeding females
  • Any condition or laboratory abnormality which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Known allergic/hypersensitivity reaction to thalidomide, lenalidomide or any components of the treatment
  • Any cutaneous grade ≥ 3 adverse reaction (for example desquamating rash) while taking thalidomide or similar drugs
  • Any prior use of lenalidomide
  • Known positive for HIV or active 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: NCT00891384

Contacts
Contact: Guido Kobbe, PD Dr. 0049-211-81-17720 Kobbe@med.uni.duesseldorf.de
Contact: Roland Fenk, Dr. 0049-211-81-19944 fenk@med.uni-duesseldorf.de

Locations
Germany
Medizinische Klinik, Abteilung Innere Medizin Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Hartmut Goldschmidt, Prof. Dr. med.    06221-56-8003    hartmut.goldschmidt@med.uni-heidelberg.de   
Contact: Kai Neben, Dr. med.    06221-56-4781    kai.neben@med.uni-heidelberg.de   
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology Recruiting
Giessen, Hessen, Germany, 35385
Contact: Matthias Rummel, PD Dr.    0049-641-994-2651    rummel@innere.med.uni-giessen.de   
Principal Investigator: Matthias Rummel, PD Dr.         
Departement of Hematology, Oncology and Clinical Immunology Recruiting
Duesseldorf, NW, Germany, 40225
Contact: Guido Kobbe, PD Dr.    0049-211-81-17720    Kobbe@med.uni-duesseldorf.de   
Contact: Roland Fenk, Dr.    0049-211-81-19944    fenk@med.uni-duesseldorf.de   
Principal Investigator: Roland Fenk, Dr.         
St. Johannes Hospital, Medical Clinic II Recruiting
Duisburg, NW, Germany, 47166
Contact: Aristoteles Giagounidis, Dr.    0040-303-546-2442    studies@email.de   
Principal Investigator: Aristoteles Giagounidis, Dr.         
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Nicolaus Kröger, Prof. Dr.    0049-40-4280-358664    nkröger@uke-uni-hamburg.de   
Principal Investigator: Nicolaus Kröger, Prof. Dr.         
Sponsors and Collaborators
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Investigators
Principal Investigator: Guido Kobbe, PD Dr. Departement of Hematology, Oncology and Clinical Immunology
  More Information

No publications provided

Responsible Party: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier: NCT00891384     History of Changes
Other Study ID Numbers: LenaMain-Trial
Study First Received: April 24, 2009
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH:
Multiple Myeloma
maintenance therapy
lenalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014