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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022282
• Other study ID #: CDR0000068801
• Secondary ID: AETERNA-AE-MM-00
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: February 27, 2013
• Start date: April 2001

Study information

• Verified date: February 2008
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• shark cartilage extract AE-941

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Country where clinical trial is conducted

Canada,