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Brief Title: Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Official Title: Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)
Study ID: NCT00925821
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Charité University Hospital - Virchow Klinikum, Berlin, , Germany
Dresden University Hospital, Dresden, , Germany
Erlangen University Hospital, Erlangen, , Germany
Freiburg University Hospital, Freiburg, , 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
Rostock University Hospital, Rostock, , Germany
Ulm University Hospital, Ulm, , Germany
Name: Ralf C Bargou, MD
Affiliation: Wuerzburg University Hospital, Dept. of Internal Medicine II
Role: PRINCIPAL_INVESTIGATOR