Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
Charité University Hospital - Virchow Klinikum
Berlin, Germany
Dresden University Hospital
Dresden, Germany
Erlangen University Hospital
Erlangen, Germany
Freiburg University Hospital
Freiburg im Breisgau, Germany
Jena University Hospital
Jena, Germany
Kiel University Hospital
Kiel, Germany
Munich Grosshadern University Hospital
Munich, Germany
University Hospital of Munich Technical University
Munich, Germany
Klinikum Nuremberg
Nuremberg, Germany
Regensburg University Hospital
Regensburg, Germany
...and 2 more locations
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
Time frame: 9 months from start of treatment
Progression-free survival (PFS)
Time frame: 9 months from start of treatment
Incidence and relationship of severe adverse events
Time frame: 1 year from start of treatment
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