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.

Phase 1

• Conditions: Patients with multiple myeloma; MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-003945-33-DE
• Lead Sponsor: Gesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified