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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
CASI Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
December 28, 2007
Last Updated
February 25, 2009
Sponsor
CASI Pharmaceuticals, Inc.
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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
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A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

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