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A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

NCT ID: NCT00592579

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed Multiple Myeloma Plateau Phase Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Open label, oral administration of 2ME2

Group Type EXPERIMENTAL

2-methoxyestradiol

Intervention Type DRUG

800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.

Interventions

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2-methoxyestradiol

800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.

Intervention Type DRUG

Other Intervention Names

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Panzem

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Be at least 18 years of age.
3. Have monoclonal plasma cells in the marrow.
4. 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.
5. Have laboratory data as specified below:

* AST and ALT \< 2.5 x upper limit of normal (ULN)
* 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
6. Have life expectancy of at least 3 months
7. Have ECOG performance status of 0, 1, or 2
8. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
9. 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.

Exclusion Criteria

1. Be pregnant or nursing.
2. Have any condition that is likely to detrimentally affect regular follow up.
3. 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.
4. Have an active infection
5. Have had major surgery within 21 days of starting 2ME2 administration
6. Have additional uncontrolled serious medical or psychiatric illness
7. have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
8. Have uncontrolled or untreated active bleeding or thrombotic disorder.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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EntreMed, Inc.

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17947482 (View on PubMed)

Other Identifiers

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ME-CL-004

Identifier Type: -

Identifier Source: org_study_id