ROCHESTER, MinnesotaPrevious studies have shown the benefits of
thalidomide (Thalomid) in patients with relapsed multiple myeloma. Now,
researchers from the Mayo Clinic report that the oral combination of
thalidomide and dexamethasone is feasible and active as initial therapy of
The phase II study involved 50 patients with previously untreated myeloma.
Thalidomide was given orally at a dose of 200 mg/d. Dexamethasone was given
orally at a dose of 40 mg/d on days 1 to 4, 9 to 12, and 17 to 20 (odd
cycles) and 40 mg/d on days 1 to 4 (even cycles), repeated monthly.
The confirmed response rate (greater than 50% reduction in M-protein in
both blood and urine) was 64% (32 patients), said lead author S. Vincent
Rajkumar, MD, of the Division of Hematology. An additional 14 patients (28%)
achieved a reduction in M-protein of 25% to 50%. Reduction in M-protein
levels was accompanied by hematologic recovery from anemia, leukopenia, and
thrombocytopenia. A total of 31 patients went on to stem cell collection
after four cycles, and 26 underwent stem cell transplantation (J Clin
Oncol 20:4319-4323, 2002).
The rate of major grade 3-4 toxicities was 32% (16 patients); the most
frequent such events were deep vein thrombosis (six patients), constipation
(four patients), rash (three patients), and dyspnea (two patients). There
were three deaths during active therapy, due to pancreatitis, pulmonary
embolism, and infection.
The authors concluded that the combination "merits further study as an
oral alternative to infusional chemotherapy with vincristine, doxorubicin,
and dexamethasone and other intravenous regimens currently used as
pretransplan-tation induction therapy for myeloma." Dr. Rajkumar is lead
investigator of an ongoing ECOG phase III study to further evaluate the
efficacy of thalidomide plus dexamethasone vs dexamethasone alone in patients
with newly diagnosed multiple myeloma.