This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone
together works in treating patients with multiple myeloma undergoing stem cell transplant.
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in
different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as
dexamethasone, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and
dexamethasone together may kill more cancer cells.
CONSOLIDATION: Patients receive bortezomib, lenalidomide, and dexamethasone (VLD) therapy
comprising bortezomib intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO)
once daily (QD) on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and
12. Courses continue for 28 days and repeat every 3 months in the absence of disease
progression or unacceptable toxicity.
In between courses of VLD, patients receive Lenalidomide + Dexamethasone (LD) therapy
comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3).
Courses continue for 28 days.
MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on
days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.
- Patients with symptomatic active multiple myeloma who have completed autotransplant
are eligible for the study; patients should be assessed for eligibility within 35
days of the transplant and treatment should commence within 10 weeks of the
- Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients
with a poor performance status (3-4) are also eligible, if complications of the bone
such as compression fracture, hyperviscosity or infection such as pneumonia have been
- No significant co-morbid medical conditions; no uncontrolled life threatening
- Unsupported platelet count > 80,000/uL
- Absolute neutrophil count (ANC) > 1000/uL
- Signed informed consent should be obtained from all patients in accordance with
institutional and federal guidelines
- Patients with a history of recent (< 6 months) myocardial infarction, unstable
angina, difficult to control congestive heart failure, uncontrolled hypertension,
difficult to control significant cardiac arrhythmias, or arrhythmia associated with
prolonged QT interval
- Pregnant or nursing women; women of child-bearing potential must have a negative
pregnancy documented within one week of registration; women/men of reproductive
potential may not participate unless they have agreed to use two forms of effective
- Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib,
thalidomide, or other agents
- Human immunodeficiency virus (HIV) positive patients
- Transaminases > 2 x normal values
- Bilirubin > 2 x normal values
- Active uncontrolled infection
- History of significant psychiatric illness; steroid induced psychosis