Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, maintenance therapy, lenalidomide
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Lenalidomide Type: Drug
Name: Lenalidomide Type: Drug
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Medizinische Klinik, Abteilung Innere Medizin
Heidelberg, Baden-Württemberg, Germany
Status: Recruiting
Contact: Hartmut Goldschmidt, Prof. Dr. med. - 06221-56-8003 - hartmut.goldschmidt@med.uni-heidelberg.de
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology
Giessen, Hessen, Germany
Status: Recruiting
Contact: Matthias Rummel, PD Dr. - 0049-641-994-2651 - rummel@innere.med.uni-giessen.de
Departement of Hematology, Oncology and Clinical Immunology
Duesseldorf, NW, Germany
Status: Recruiting
Contact: Guido Kobbe, PD Dr. - 0049-211-81-17720 - Kobbe@med.uni-duesseldorf.de
St. Johannes Hospital, Medical Clinic II
Duisburg, NW, Germany
Status: Recruiting
Contact: Aristoteles Giagounidis, Dr. - 0040-303-546-2442 - studies@email.de
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf
Hamburg, Germany
Status: Recruiting
Contact: Nicolaus Kröger, Prof. Dr. - 0049-40-4280-358664 - nkröger@uke-uni-hamburg.de
Start Date
April 2009
Completion Date
June 2018
Sponsors
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Source
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page