Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance

• Understand and voluntarily sign an informed consent form
• Patients willing and able to undergo autologous and allogeneic transplantation
• no previous systemic therapy for the treatment of multiple myeloma (dexamethasone at a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy, local irradiation of bone lesions; and surgical intervention is accepted as pretreatment)
• Newly diagnosed multiple myeloma according to common diagnostic criteria including presence of CRAB and measurable disease parameters
• Cardiac ejection fraction (LVEF) of at least 50%
• Corrected DLCO of at least 50% ; alternatively pO2 [art.] of at least 70mmHg
• Karnofsky performance status of greater or equal to 50%
• adequate bone marrow function
• adequate serum chemistry values
• Use of adequate contraception for female subjects with childbearing potential and male subjects
• Bone marrow sample available for analysis of molecular cytogenetics
• Able to administer low molecular-weight heparin as a prophylactic anticoagulation therapy for the first three months(applicable for subjects randomized to RAD) and able to administer ASS 100 mg/d (applicable for subjects randomized to VRD)

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or lactating females
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk
• History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or peri-/myocarditis
• Use of any other experimental drug or therapy within 28 days of baseline
• Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
• Known intolerance of boron
• Hypersensitivity to acyclovir or similar anti-viral drug
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
• HIV positive, active hepatitis B, C or D viral infection, known CMV reactivation/active infection, EBV reactivation/active infection or treponema pallidum infection
• Uncontrolled diabetes mellitus
• Non-secretory MM
• Clinically relevant active infection or serious co-morbid medical conditions