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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00022282

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

A Phase 2 study testing shark cartilage extract AE-941 in people with Multiple Myeloma and Plasma Cell Neoplasm, run by AEterna Zentaris at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
shark cartilage extract AE-941
How many people
Not given
Where
1 siteCanada
Study dates
Apr 2001to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Study site

    Québec

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
shark cartilage extract AE-941
Keywords
refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • shark cartilage extract AE-941Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022282
Sponsor's protocol ID
CDR0000068801
Other IDs
AETERNA-AE-MM-00-02
Status last verified
Feb 2008
First submitted
10 Aug 2001
Last updated
28 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing shark cartilage extract AE-941 in people with Multiple Myeloma and Plasma Cell Neoplasm, run by AEterna Zentaris at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.

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