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

NCT00891384 | Completed Phase 3 DMC

• 1 other identifier: LenaMain-Trial
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; maintenance therapy; lenalidomide

Outcome Measures

Primary Outcomes (1)

• event-free survival

  6 years

Secondary Outcomes (3)

• safety, tolerability and feasibility

  6 month

• Improvement of remission rate

  6 years

• evaluate quality of life

  6 years

Study Arms (2)

1

EXPERIMENTAL

25 mg lenalidomide

Drug: Lenalidomide

2

EXPERIMENTAL

5 mg lenalidomide

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

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.

Also known as: Revlimid

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead

Study Sites (5)

Medizinische Klinik, Abteilung Innere Medizin

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology

Giessen, Hesse, 35385, Germany

Location

St. Johannes Hospital, Medical Clinic II

Duisburg, Northwest, 47166, Germany

Location

Departement of Hematology, Oncology and Clinical Immunology

Düsseldorf, Northwest, 40225, Germany

Location

Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guido Kobbe, PD Dr.

  Departement of Hematology, Oncology and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2009
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

DE (5)