Relapsed Multiple MyelomaPhase 2NCT00592579
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
A Phase 2 study testing 2-methoxyestradiol in people with Relapsed Multiple Myeloma and Plateau Phase Multiple Myeloma, run by CASI pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Multiple Myeloma, Plateau Phase Multiple Myeloma
- What is being tested?
- 2-methoxyestradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2001to Sep 2008
- 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
Who may be able to join
- Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
- Be at least 18 years of age.
- Have monoclonal plasma cells in the marrow.
- have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.
- Have laboratory data as specified below:
- AST and ALT < 2.5 x upper limit of normal (ULN)
Show all 16Show fewer
- Alk phos < 5.0 x ULN
- direct bilirubin < 2 x ULN
- Creatinine < 3.0 x ULN
- ANC greater than or equal to 750 cells/mm3
- Platelets > 25,000/mm3
- Hemoglobin greater than or equal to 7.0g/dL
- Have life expectancy of at least 3 months
- Have ECOG performance status of 0, 1, or 2
- Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
- Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.
Who cannot join
- Be pregnant or nursing.
- Have any condition that is likely to detrimentally affect regular follow up.
- Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
- Have an active infection
- Have had major surgery within 21 days of starting 2ME2 administration
- Have additional uncontrolled serious medical or psychiatric illness
- have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
- Have uncontrolled or untreated active bleeding or thrombotic disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.
- Being tested
- 2-methoxyestradiol
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-methoxyestradiolDrug
Also called Panzem
800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open label, oral administration of 2ME2 Receives: Drug: 2-methoxyestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
Measured: At least yearly
Secondary outcomes (2)
To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma
Measured: As reported
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma
Measured: At least yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startMar 2001
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed Multiple MyelomaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592579
- Sponsor's protocol ID
- ME-CL-004
- Status last verified
- Feb 2009
- First submitted
- 28 Dec 2007
- Last updated
- 26 Feb 2009
- Results posted
- No
Publications
Rajkumar SV, Richardson PG, Lacy MQ, Dispenzieri A, Greipp PR, Witzig TE, Schlossman R, Sidor CF, Anderson KC, Gertz MA. Novel therapy with 2-methoxyestradiol for the treatment of relapsed and plateau phase multiple myeloma. Clin Cancer Res. 2007 Oct 15;13(20):6162-7. doi: 10.1158/1078-0432.CCR-07-0807.
PubMed 17947482
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00592579
- Acronym / sponsor ID
- ME-CL-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Jan 2008 (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.
The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 2-methoxyestradiolOpen label, oral administration of 2ME2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
- Be at least 18 years of age.
- Have monoclonal plasma cells in the marrow.
- have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.
- Have laboratory data as specified below:
Key exclusion criteria (8 listed)
- Be pregnant or nursing.
- Have any condition that is likely to detrimentally affect regular follow up.
- Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
- Have an active infection
- Have had major surgery within 21 days of starting 2ME2 administration
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 |
|---|---|---|
| 2-methoxyestradiolAlso: Panzem800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg. | Drug | 1 |
Primary outcome
To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
Time frame: At least yearly
2 secondary outcomes
To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma
Time frame: As reported
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma
Time frame: At least yearly
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 26 Feb 2009.
- Results publication: PubMed 17947482Rajkumar SV, Richardson PG, Lacy MQ, Dispenzieri A, Greipp PR, Witzig TE, Schlossman R, Sidor CF, Anderson KC, Gertz MA. Novel therapy with 2-methoxyestradiol for the treatment of relapsed and plateau phase multiple myeloma. Clin Cancer Res. 2007 Oct 15;13(20):6162-7. doi: 10.1158/1078-0432.CCR-07-0807.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-methoxyestradiol in people with Relapsed Multiple Myeloma and Plateau Phase Multiple Myeloma, run by CASI pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. 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 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does the primary outcome measure?
To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma (time frame: At least yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592579, which also lists 1 linked publication.
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 26 Feb 2009.