Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV
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