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

Relapsed Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592579
• Other study ID #: ME-CL-004
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2007
• Last updated: February 25, 2009
• Start date: March 2001
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: CASI Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
CASI Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & 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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes