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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Lenalidomide

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, maintenance therapy, lenalidomide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Medizinische Klinik, Abteilung Innere Medizin
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology
Departement of Hematology, Oncology and Clinical Immunology
St. Johannes Hospital, Medical Clinic II
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

25 mg lenalidomide

5 mg lenalidomide

Outcomes

Primary Outcome Measures

event-free survival

Secondary Outcome Measures

safety, tolerability and feasibility

Improvement of remission rate

evaluate quality of life

Full Information

NCT ID

NCT00891384

First Posted

April 24, 2009

Last Updated

January 17, 2018

Sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

1. Study Identification

Unique Protocol Identification Number

NCT00891384

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 1, 2009 (Actual)

Primary Completion Date

June 22, 2017 (Actual)

Study Completion Date

June 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, maintenance therapy, lenalidomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

25 mg lenalidomide

Arm Title

Arm Type

Experimental

Arm Description

5 mg lenalidomide

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid

Intervention Description

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

Primary Outcome Measure Information:

Title

event-free survival

Time Frame

6 years

Secondary Outcome Measure Information:

Title

safety, tolerability and feasibility

Time Frame

6 month

Title

Improvement of remission rate

Time Frame

6 years

Title

evaluate quality of life

Time Frame

6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guido Kobbe, PD Dr.

Organizational Affiliation

Departement of Hematology, Oncology and Clinical Immunology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medizinische Klinik, Abteilung Innere Medizin

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

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

City

Giessen

State/Province

Hessen

ZIP/Postal Code

35385

Country

Germany

Facility Name

Departement of Hematology, Oncology and Clinical Immunology

City

Duesseldorf

State/Province

Northwest

ZIP/Postal Code

40225

Country

Germany

Facility Name

St. Johannes Hospital, Medical Clinic II

City

Duisburg

State/Province

Northwest

ZIP/Postal Code

47166

Country

Germany

Facility Name

Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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