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

NCT00022282 | Completed Phase 2

• 2 other identifiers: CDR0000068801AETERNA-AE-MM-00-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Interventions

shark cartilage extract AE-941 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AEterna Zentaris: lead

Study Sites (1)

Unknown Facility

Québec, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

shark cartilage extract

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: October 15, 2003
• Study Start: April 1, 2001
• Primary Completion: March 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2008-02

Locations

CA (1)