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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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

OBJECTIVES: I. Determine the response rate and response duration of patients with refractory
or relapsed multiple myeloma treated with SU5416. II. Determine the toxicity of SU5416 in
this patient population.

OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour twice weekly.
Treatment continues in the absence of unacceptable toxicity or disease progression. Patients
are followed for survival.

PROJECTED ACCRUAL: A total of 20-38 patients will be accrued for this study within 2 years.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitchell R. Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838