Patients with multiple myeloma MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Revlimid (5 mg)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Gesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Understand and voluntarily sign an informed consent form. - Age 18-75 years at the time of signing the informed consent form. - 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 a second high-dose therapy in case of less than a vgPR or due to conditioning with intermediate dose melphalan because of an age of more than 65 years. - Patients may have received up to 6 cycles of prior induction therapy (e.g. idarubicine, dexamethasone) and up to 2 cycles of prior mobilisation chemotherapy (e.g. cyclophosphamide). A bortezomib or thalidomide containing induction therapy is allowed. Patients may also have received prior radiation therapy. The use of lenalidomide as monotherapy or as part of a combination treatment for induction therapy is not allowed. - 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 of £ 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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. (Lactating females must agree not to breast feed while taking lenalidomide). - 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 hypersensitivity to thalidomide. - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. - Any prior use of thalidomide or lenalidomide. - Known positive for HIV or active infectious hepatitis, type A, B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the event-free survival (EFS) of patients with multiple myeloma who receive two different dose levels (25 vs. 5 mg daily) of lenalidomide as maintenance therapy after first line high-dose therapy and autologous stem cell transplantation.;Secondary Objective: - Evaluate safety, tolerability, and feasibility during consolidation (25 mg) and maintenance (25mg vs. 5 mg) therapy with lenalidomide. - Evaluate the improvement of remission rates during consolidation therapy with lenalidomide and compare remissions rates during maintenance therapy with two doses of lenalidomide. - Evaluate the quality of life of patients during consolidation and maintenance therapy with lenalidomide.;Primary end point(s): - Compare the event-free survival of patients with multiple myeloma who receive two different dose levels (25 vs. 5 mg daily) of lenalidomide as maintenance therapy after first line high-dose therapy and autologous stem cell transplantation.;Timepoint(s) of evaluation of this end point: disease progession | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability number of SAE - remission rate - overall survival - Quality of life (QoL) - progression-free Survival 2 (PFS2);Timepoint(s) of evaluation of this end point: every visit until disease progression | — |
Countries
Germany
Contacts
Public ContactCRA - Clinical Research Associate
Gesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)
Outcome results
None listed