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

Sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH (Other)

Overall Status

Completed

CT.gov ID

NCT00891384

Collaborator

(none)

194

Enrollment

Locations

Arms

98.7

Actual Duration (Months)

38.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Lenalidomide Drug: Lenalidomide	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jun 22, 2017

Actual Study Completion Date :

Jun 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 25 mg lenalidomide	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. Other Names: Revlimid
Experimental: 2 5 mg lenalidomide	Drug: 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 Other Names: Revlimid

Arm

Intervention/Treatment

Experimental: 1

25 mg lenalidomide

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.

Other Names:

Revlimid

Experimental: 2

5 mg lenalidomide

Drug: 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

Other Names:

Revlimid

Outcome Measures

Primary Outcome Measures

event-free survival [6 years]

Secondary Outcome Measures

safety, tolerability and feasibility [6 month]
Improvement of remission rate [6 years]
evaluate quality of life [6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Klinik, Abteilung Innere Medizin	Heidelberg	Baden-Württemberg	Germany	69120
2	Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology	Giessen	Hessen	Germany	35385
3	Departement of Hematology, Oncology and Clinical Immunology	Duesseldorf	Northwest	Germany	40225
4	St. Johannes Hospital, Medical Clinic II	Duisburg	Northwest	Germany	47166
5	Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf	Hamburg		Germany	20246