Multiple Myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago) MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form 2. Age >18 years at the time of signing the informed consent form 3. Able to adhere to the study visit schedule and other protocol requirements 4. Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago) 5. No active acute GvHD (grade II – IV) 6. No active infectious complications 7. ECOG performance status of 3.0 x 10^9/l • Platelet count > 80 x 10^9/l • Serum creatinine 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide) 3. Use of any other experimental drug or therapy within 28 days of baseline 4. Known hypersensitivity to thalidomide 5. Concurrent use of other anti-cancer agents or treatments 6. Known positive for HIV or infectious hepatitis, type A, B, or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma;Secondary Objective: • Monitoring of remission status by free-light chain assay, serum-immunoglobulin and/or PCR technique (patient-specific primers) • Monitoring of T-cell subpopulations and NK-cell activity after lenalidomide treatment • Incidence of graft-versus-host disease. ;Primary end point(s): Maximale tolerable dose of Lenalidomide as maintenance therapy after allogeneic stem cell transplantation | — |
Countries
Germany
Outcome results
None listed