Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Summary: RATIONALE: AE-941 may help to slow the growth of multiple myeloma.
  PURPOSE: Phase II trial to study the effectiveness of neovastat in treating patients who have relapsed or refractory multiple myeloma.

Detailed description: OBJECTIVES:
  -  Determine the confirmed tumor response rate in patients with early relapse or refractory multiple myeloma treated with AE-941 (Neovastat).
  -  Determine the safety of this drug in these patients.
  -  Evaluate the time to progression in patients treated with this drug.
  -  Evaluate the duration of tumor response (partial response, response, and complete response) in patients treated with this drug.
  OUTLINE: This is a multicenter, open-label study.
  Patients receive oral AE-941 (Neovastat) twice daily.
  Patients are followed every 4 weeks until disease progression.
  PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of multiple myeloma (MM) according to the Durie and Salmon criteria
  -  Refractory to or in early relapse after standard chemotherapy with or without stem cell transplantation
  -  Measurable disease
  -  Quantifiable IgM, IgG, or IgA paraprotein in serum AND/OR
  -  Bence-Jones protein in urine
  -  No plasma cell leukemia (more than 20% plasma cells in peripheral blood and an absolute plasma cell count of at least 2,000/mm3)
  -  No nonsecretory MM
  -  No spinal cord compression
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  More than 6 months
  Hematopoietic:
  -  No clinical symptoms of hyperviscosity
  Hepatic:
  -  Not specified
  Renal:
  -  Creatinine no greater than 2 times upper limit of normal
  -  Calcium no greater than 11 mg/dL
  Other:
  -  No other prior malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  -  No severe allergy to fish or seafood
  -  No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection)
  -  No significant medical or psychiatric condition that would preclude study participation
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use adequate contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  See Disease Characteristics
  -  No prior history of treatment with thalidomide for more than 14 days duration
  -  At least 4 weeks since prior biological therapy for MM
  -  Concurrent epoetin alfa allowed
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 4 weeks since prior chemotherapy for MM
  Endocrine therapy:
  -  At least 4 weeks since prior steroid therapy for MM
  -  No prednisone maintenance therapy
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy
  -  No concurrent palliative or curative radiotherapy
  Surgery:
  -  Not specified
  Other:
  -  At least 28 days since other prior shark cartilage products
  -  At least 28 days since other prior experimental therapeutic agents
  -  Concurrent monthly bisphosphonate (pamidronates) infusions allowed
  -  No other concurrent anticancer treatment
  -  No other concurrent shark cartilage products
  -  No other concurrent therapies for MM

Relevance to patient case: not relevant