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Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

CDR0000068801

NCT ID:

NCT00022282

Start Date:

April 2001

Completion Date:

Related Keywords:

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

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