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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891384
First Posted: May 1, 2009
Last Update Posted: September 6, 2017
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.
Information provided by (Responsible Party):
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • safety, tolerability and feasibility [ Time Frame: 6 month ]
  • Improvement of remission rate [ Time Frame: 6 years ]
  • evaluate quality of life [ Time Frame: 6 years ]

Enrollment: 194
Actual Study Start Date: April 1, 2009
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: December 31, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00891384


Locations
Germany
Medizinische Klinik, Abteilung Innere Medizin
Heidelberg, Baden-Württemberg, Germany, 69120
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology
Giessen, Hessen, Germany, 35385
Departement of Hematology, Oncology and Clinical Immunology
Duesseldorf, NW, Germany, 40225
St. Johannes Hospital, Medical Clinic II
Duisburg, NW, Germany, 47166
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
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

Responsible Party: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier: NCT00891384     History of Changes
Other Study ID Numbers: LenaMain-Trial
First Submitted: April 24, 2009
First Posted: May 1, 2009
Last Update Posted: September 6, 2017
Last Verified: September 2017

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
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
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents