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.
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
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- 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.
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.
- First posted15 Oct 2003 (estimated)
- Study startApr 2001
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT00022282
- Acronym / sponsor ID
- CDR0000068801
- Keywords
- refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Mar 2007 (actual)
- First posted
- 15 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shark cartilage extract AE-941 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.