Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, maintenance therapy, lenalidomide
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 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.
Interventions
DRUGLenalidomide
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.
Sponsors
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event-free survival | 6 years |
Secondary
| Measure | Time frame |
|---|---|
| safety, tolerability and feasibility | 6 month |
| Improvement of remission rate | 6 years |
| evaluate quality of life | 6 years |
Countries
Germany
Outcome results
None listed