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Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Relapsed Multiple Myeloma, Plateau Phase Multiple Myeloma

Thank you

Trial Information

Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

At least yearly

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2001

Completion Date:

September 2008

Related Keywords:

  • Relapsed Multiple Myeloma
  • Plateau Phase Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mayo Clinic Rochester, Minnesota  55905
Dana Farber Cancer Institute Boston, Massachusetts  02115