UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Inclusion Criteria:

• Patients must have newly diagnosed active multiple myeloma requiring treatment.Patients with a previous history of smoldering myeloma will be eligible if there isevidence of progressive disease requiring chemotherapy.

• Protein criteria must be present in order to evaluate response.Non-secretory patientsare eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focalplasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence ofhematopoietic growth factors is seen.

• All necessary baseline studies for determining stage, bloodwork, and bone marrow mustbe obtained within 35 days prior to registration.

• Patients must have received no more than one cycle of prior chemotherapy including onemonth of Dexamethasone and Thalidomide for this disease. Patients may have receivedprior radiotherapy provided approval has been obtained by one of the studycoordinators.

• Patients must have a performance status of 0-2 based on SWOG criteria. Patients with apoor performance status (3-4), based solely on bone pain, will be eligible.

• Patients with renal failure, even if on dialysis, are eligible if it is felt to be dueto myeloma and if the duration of renal failure does not exceed two months

• Patients must be 75 years of age or less at the time of registration

• All patients must be informed of the investigational nature of this study and mustsign and give written informed consent in accordance with institutional and federalguidelines.

• If medically appropriate, patients with pathologic fractures, pneumonia at diagnosisor hyperviscosity with shortness of breath should have these conditions attended toprior to registration.

Exclusion Criteria:

• Patients must not have significant co-morbid medical conditions or uncontrolled lifethreatening infection

• Patients must not have uncontrolled diabetes

• Patients with recent (< or =6 months) myocardial infarction, unstable angina,difficult to control congestive heart failure, uncontrolled hypertension, or difficultto control cardiac arrythmias are ineligible. Ejection fraction by ECHO or MUGA shouldbe within the institutional normal range and must be performed within 42 days prior toregistration.

• Patients must not have a history of chronic obstructive or chronic restrictivepulmonary disease.

• No prior malignancy is allowed except for adequately treated basal cell or squamouscell skin cancer, in situ cervical cancer, or other cancer for which the patient hasbeen disease free for at least three years.Prior malignancy is acceptable providedthere has been no evidence of disease within the three-year interval and there must beno prior treatment with cytotoxic drugs that could potentially be assigned on thistreatment protocol.

• Pregnant or nursing women may not participate. Women of child-bearing potential musthave a negative pregnancy documented within one week of registration. Women/men ofreproductive potential may not participate unless they have agreed to use two forms ofeffective contraceptive method.