Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Procedure: allogeneic stem cell transplant versus second autologous transplantationDrug: RAD
- Registration Number
- NCT00925821
- Lead Sponsor
- Wuerzburg University Hospital
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- Written informed consent
- Newly diagnosed multiple myeloma
- Maximum of one prior systemic therapy (2 cycles)
- Presence of CRAB criteria
- Measurable disease parameters
- Left ventricular ejection fraction at least 55%
- DLCO of at least 60%
- Adequate bone marrow function
- Use of adequate contraception for female subjects with childbearing potential and all male subjects
- Eligible for autologous and allogeneic stem cell transplantation
- Bone marrow baseline sample evaluable for interphase cytogenetics
- Any serious medical conditions preventing the subject from written informed consent
- Progressive disease (PD) to any initial treatment
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data
- Use of any other experimental drug or therapy within 28 days of baseline
- Preexisting neuropathy of ≥ grade 2 severity
- Known hypersensitivity to thalidomide
- Any prior use of lenalidomide
- Positive for HIV or infectious hepatitis, type A, B or C after serologic testing
- Serum creatinine despite induction therapy ≥ 2.0 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-dose melphalan chemotherapy RAD Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells Allogeneic stem cell transplant allogeneic stem cell transplant versus second autologous transplantation Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine Allogeneic stem cell transplant RAD Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine High-dose melphalan chemotherapy allogeneic stem cell transplant versus second autologous transplantation Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
- Primary Outcome Measures
Name Time Method Response rate to RAD induction and transplant (stringent CR, CR, very good PR) 9 months from start of treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 9 months from start of treatment Incidence and relationship of severe adverse events 1 year from start of treatment
Trial Locations
- Locations (12)
Ulm University Hospital
🇩🇪Ulm, Germany
Dresden University Hospital
🇩🇪Dresden, Germany
University Hospital of Munich Technical University
🇩🇪Munich, Germany
Regensburg University Hospital
🇩🇪Regensburg, Germany
Rostock University Hospital
🇩🇪Rostock, Germany
Freiburg University Hospital
🇩🇪Freiburg, Germany
Jena University Hospital
🇩🇪Jena, Germany
Munich Grosshadern University Hospital
🇩🇪Munich, Germany
Klinikum Nuremberg
🇩🇪Nuremberg, Germany
Kiel University Hospital
🇩🇪Kiel, Germany
Charité University Hospital - Virchow Klinikum
🇩🇪Berlin, Germany
Erlangen University Hospital
🇩🇪Erlangen, Germany