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A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

Phase 3
18 Years
75 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

event-free survival

Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Guido Kobbe, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Departement of Hematology, Oncology and Clinical Immunology


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • maintenance therapy
  • lenalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell