Status:
COMPLETED
Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
Lead Sponsor:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 autologo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2017
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00891384
Start Date
April 1 2009
End Date
June 22 2017
Last Update
January 19 2018
Active Locations (5)
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1
Medizinische Klinik, Abteilung Innere Medizin
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology
Giessen, Hesse, Germany, 35385
3
St. Johannes Hospital, Medical Clinic II
Duisburg, Northwest, Germany, 47166
4
Departement of Hematology, Oncology and Clinical Immunology
Düsseldorf, Northwest, Germany, 40225