Phase II Trial of SU5416 as Treatment for Refractory/Relapsed Multiple Myeloma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma with an elevated
monoclonal protein in serum and/or urine No history of CNS lesion or CNS bleed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Cytopenias secondary to multiple myeloma involvement of bone
marrow allowed Cytopenias not due to multiple myeloma require: WBC at least 3,000/mm3
Platelet count at least 75,000/mm3 Hepatic: Transaminases no greater than 2 times upper
limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0
mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart
failure, severe peripheral vascular disease, or significant arrhythmia No poorly
controlled systolic or diastolic hypertension No uncompensated coronary artery disease No
history of myocardial infarction or severe/unstable angina within past 6 months No known
hypercoagulable state or deep venous or arterial thrombosis within past 3 months
Pulmonary: No pulmonary embolism within past 3 months Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 3
months after study No other severe medical or psychiatric condition (e.g., active peptic
ulcer, active infection, or history of severe alcohol or drug abuse) No known
hypersensitivity to paclitaxel or Cremophor

PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Chemotherapy: At least 1 but
no more than 3 prior chemotherapy regimens Induction followed by high dose therapy with
stem cell support considered a single treatment regimen Tandem courses of high dose
therapy considered as 2 regimens Endocrine therapy: At least 1 prior regimen containing
steroids Radiotherapy: Prior radiotherapy for symptom control allowed Surgery: At least 3
weeks since prior major surgery At least 1 year since prior coronary artery surgery,
angioplasty, or stent placement No prior brain surgery Other: No other concurrent
investigational drugs Concurrent bisphosphonates (e.g., pamidronate) allowed