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

This is an interventional treatment trial for Previously Untreated Symptomatic Multiple Myeloma focused on measuring multiple myeloma, autologous stem cell transplant, allogeneic stem cell transplant, lenalidomide, bortezomib Read More

Inclusion Criteria:

• 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