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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891384
• Other study ID #: LenaMain-Trial
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2009
• Last updated: January 17, 2018
• Start date: April 1, 2009
• Est. completion date: June 22, 2017

Study information

• Verified date: January 2018
• Source: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide
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.
• Lenalidomide
Patients will receive maintenance therapy according to their assigned treatment arm:5 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

Locations

Country	Name	City	State
Germany	Departement of Hematology, Oncology and Clinical Immunology	Duesseldorf	Northwest
Germany	St. Johannes Hospital, Medical Clinic II	Duisburg	Northwest
Germany	Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology	Giessen	Hessen
Germany	Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf	Hamburg
Germany	Medizinische Klinik, Abteilung Innere Medizin	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival		6 years
Secondary	safety, tolerability and feasibility		6 month
Secondary	Improvement of remission rate		6 years
Secondary	evaluate quality of life		6 years