NCT00592579

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

7.5 years

First QC Date

December 28, 2007

Last Update Submit

February 25, 2009

Conditions

Relapsed Multiple MyelomaPlateau Phase Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma

    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

    As reported

  • To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma

    At least yearly

Study Arms (1)

1

EXPERIMENTAL

Open label, oral administration of 2ME2

Drug: 2-methoxyestradiol

Interventions

2-methoxyestradiolDRUG

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

Also known as: Panzem
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 17947482RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

2-Methoxyestradiol

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 14, 2008

Study Start

March 1, 2001

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

US(2)