A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
Primary Purpose
Relapsed Multiple Myeloma, Plateau Phase Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2-methoxyestradiol
Sponsored by

About this trial
This is an interventional treatment trial for Relapsed Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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:
- 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.
Sites / Locations
- Dana Farber Cancer Institute
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Open label, oral administration of 2ME2
Outcomes
Primary Outcome Measures
To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
Secondary Outcome Measures
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
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma
Full Information
NCT ID
NCT00592579
First Posted
December 28, 2007
Last Updated
February 25, 2009
Sponsor
CASI Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00592579
Brief Title
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
Official Title
Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CASI Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Multiple Myeloma, Plateau Phase Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Open label, oral administration of 2ME2
Intervention Type
Drug
Intervention Name(s)
2-methoxyestradiol
Other Intervention Name(s)
Panzem
Intervention Description
800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
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.
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17947482
Citation
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.
Results Reference
result
Learn more about this trial
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
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