Overview

Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Wuerzburg University Hospital
Collaborators:
Amgen
Celgene Corporation
ClinAssess GmbH
medac GmbH
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Lenalidomide
Liposomal doxorubicin
Melphalan
Thalidomide