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

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Lenalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00891384

LenaMain-Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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