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

• Status: Completed
• Trial end date: 2017-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH; Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
• Treatments: Lenalidomide; Thalidomide

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